Lifecycle

Product Profile & Quality Target

QTPP (Quality Target Product Profile): Define Quality targets such as clinical relevance, efficacy, and safety.

4TE Consulting | RESEARCH & DEVELOPMENT

Process Development Acceleration;
QTPP (Quality Target Product Profile);
CQA definition;
Risk Assessment Studies;
Design Space Definition;
Data-Driven Analysis: Use of QbD tools (MVDA, DoE, PAT);
Control Strategy Development;
Check Points / Gap Analysis (Process & Product Understanding);
Scale-Up/Scale-Down Qualified Models;
Tech transfer – from R&D to pilot scale;
CMC Studies;
Support in Formulation, Manufacturing process and analytical methods development;
Biosimilarity and Bioequivalence comparability studies;
Knowledge Harvest;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Strategic Advising on BAT (Best Available Technologies);
Regulatory Submission Support for novel methodologies.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Process outline using prior knowledge

Perform Initial Risk assessment, to identify Critical Quality Attributes (CQA), Key Process Parameters (KPP), Critical Material Attributes (CMA), Key Performance Indicators (KPI) and Critical Process Parameters (CPP).

4TE Consulting | RESEARCH & DEVELOPMENT

Process Development Acceleration;
QTPP (Quality Target Product Profile);
CQA definition;
Risk Assessment Studies;
Design Space Definition;
Data-Driven Analysis: Use of QbD tools (MVDA, DoE, PAT);
Control Strategy Development;
Check Points / Gap Analysis (Process & Product Understanding);
Scale-Up/Scale-Down Qualified Models;
Tech transfer – from R&D to pilot scale;
CMC Studies;
Support in Formulation, Manufacturing process and analytical methods development;
Biosimilarity and Bioequivalence comparability studies;
Knowledge Harvest;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Regulatory Submission Support for novel methodologies.
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Regulatory Submission Support for novel methodologies.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Process Development

Establish a relationship between the process inputs (material attributes and process parameters) and Critical Quality Attributes (CQA);
Perform Risk assessment and Risk control;
Development of formulation, manufacturing process and analytical methods (support).

4TE Consulting | RESEARCH & DEVELOPMENT

Process Development Acceleration;
QTPP (Quality Target Product Profile);
CQA definition;
Risk Assessment Studies;
Design Space Definition;
Data-Driven Analysis: Use of QbD tools (MVDA, DoE, PAT);
Control Strategy Development;
Check Points / Gap Analysis (Process & Product Understanding);
Scale-Up/Scale-Down Qualified Models;
Tech transfer – from R&D to pilot scale;
CMC Studies;
Support in Formulation, Manufacturing process and analytical methods
development;
Biosimilarity and Bioequivalence comparability studies;
Knowledge Harvest;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Strategic Advising on BAT (Best Available Technologies);
Regulatory Submission Support for novel methodologies.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | Risk Register

RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Process Design Space

Use Scientific knowledge acquired, and risk assessment performed during Process Development;
Use QbD tools such as Multivariate Data Analysis (MVDA), Design of Experiments (DoE), Process Analytical Technologies (PAT);
Description of Multi-dimensional Space that includes the various combinations that assure product quality.

4TE Consulting | RESEARCH & DEVELOPMENT

Process Development Acceleration;
QTPP (Quality Target Product Profile);
CQA definition;
Risk Assessment Studies;
Design Space Definition;
Data-Driven Analysis: Use of QbD tools (MVDA, DoE, PAT);
Control Strategy Development;
Check Points / Gap Analysis (Process & Product Understanding);
Scale-Up/Scale-Down Qualified Models;
Tech transfer – from R&D to pilot scale;
CMC Studies;
Support in Formulation, Manufacturing process and analytical methods development;
Biosimilarity and Bioequivalence comparability studies;
Knowledge Harvest;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Regulatory Submission Support for novel methodologies.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Define product Control Strategy

Define control strategy based on Design Space and Process Development

4TE Consulting | RESEARCH & DEVELOPMENT

Process Development Acceleration;
QTPP (Quality Target Product Profile);
CQA definition;
Risk Assessment Studies;
Design Space Definition;
Data-Driven Analysis: Use of QbD tools (MVDA, DoE, PAT);
Control Strategy Development;
Check Points / Gap Analysis (Process & Product Understanding);
Scale-Up/Scale-Down Qualified Models;
Tech transfer – from R&D to pilot scale;
CMC Studies;
Support in Formulation, Manufacturing process and analytical methods development;
Biosimilarity and Bioequivalence comparability studies;
Knowledge Harvest;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Strategic Advising on BAT (Best Available Technologies);
Regulatory Submission Support for novel methodologies.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

PPQ Campaign & Process QualiFIcation

Risk Based CQV;
Process Revised Risk Assessment;
Qualification Plan;
User Requirement Specification (URS);
Analytical package support (PAT, IPC, release methods);
Process Performance Qualification (PPQ) activities (support);
Evaluate Process Design to determine if the process is capable of reproducible commercial manufacturing;
Gap Analysis and Process improvement (support);
CSV (support).

4TE Consulting | Industrialization

Risk based CQV;
Risk Assessment studies;
Process Robustness Screening;
Control Strategy Definition;
Qualification Plan;
Process Performance Qualification (PPQ) activities support;
Scale-up/tech transfer to commercial scale;
Tech Transfer from sponsors to CDMO (risk-based assessment and KPI
definition);
Analytical package support (PAT, IPC, release methods);
QMS Gap assessment (ICH Q8 thr Q14) and SOP revision;
Gap Analysis and Process improvement support;
CSV support;
Regulatory Submission Support;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control).

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | Risk Register

RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Make your manufacturing facilities and production equipment efforts more effective, leaner, simpler and faster;
Ensure risk and science-based decisions;
Build reports including requirements, critical aspects and Qualification plans
results;
Guarantee a fully covered CQV lifecycle by Design Reviews;
Track and evaluate all types of changes in a single centralized system;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Regulatory Submission

Product registration and submission to authorities’ (support), in order to get a Marketing Authorization Approval (MAA);
Delivery of Common Technical Documents (CTD): QRM Strategy, CQAs, Design Space and Control Strategy.

4TE Consulting | Industrialization

Risk based CQV;
Risk Assessment studies;
Process Robustness Screening;
Control Strategy Definition;
Qualification Plan;
Process Performance Qualification (PPQ) activities support;
Scale-up/tech transfer to commercial scale;
Tech Transfer from sponsors to CDMO (risk-based assessment and KPI
definition);
Analytical package support (PAT, IPC, release methods);
QMS Gap assessment (ICH Q8 thr Q14) and SOP revision;
Gap Analysis and Process improvement support;
CSV support;
Regulatory Submission Support;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control).

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Continuous Improvement

Continued Process Verification (CPV); Lifecycle Management;
Technology transfer (support);
Site Transfer (support);
Process Scale Transfers (support);
Control Strategy verification and adjustment;
Suppliers re-assessment;
QMS Gap assessment (ICH Q8 to Q14) and SOP revision;
In-Process Monitoring & Control;
Retrospective QbD implementation for legacy products; Stability data-analysis (support);
Product Quality Review (support);
Risk-based post-approval Change Management; Reformulation and Process optimization (support); Change Control Risk Assessments;
Comparability Studies;
Knowledge aggregation & Management;
CSV (support);
Audit preparation (support).

4TE Consulting | COMMERCIAL OPERATIONS

E2E Process lifecycle management;
Risk Assessment studies;
Site Transfer support;
Process Scale Transfers Support (Up or Down);
Comparability Studies;
Data-driven troubleshooting;
Knowledge/ Portfolio Management;
Multivariate Condition Monitoring;
Integration of Process Analytical Technologies (PAT);
Continued Process Verification (CPV) / On-going Process Verification (OPV) ;
Control Strategy verification;
Reformulation and Process optimization support;
Product Quality Review (PQR) support;
Retrospective QbD implementation for legacy products;
Post-approval Change Management & Submissions;
Audit Support;
Digital Twins/ Predictive analytics and modeling;
Root Cause Analysis;
CSV support;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | Risk Register

RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.

• Identify, quantify and prioritize risks related to your business in a user-friendly manner;
Formulate risk mitigation strategies and follow-up on the actions;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time with automatic reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Biosimilar studies (Biopharma)

Study Design;
Benefit-risk assessment (support);
Perform comparative studies such as pharmacokinetic (PK), pharmaco-dynamic (PD), safety, efficacy and immunogenicity;
Analytical comparison of both biosimilar and reference products to establish molecular similarity using physicochemical and functional assays.

4TE Consulting | Research & Development

Process Development Acceleration;
QTPP (Quality Target Product Profile);
CQA definition;
Risk Assessment Studies;
Design Space Definition;
Data-Driven Analysis: Use of QbD tools (MVDA, DoE, PAT);
Control Strategy Development;
Check Points / Gap Analysis (Process & Product Understanding);
Scale-Up/Scale-Down Qualified Models;
Tech transfer – from R&D to pilot scale;
CMC Studies;
Support in Formulation, Manufacturing process and analytical methods development;
Biosimilarity and Bioequivalence comparability studies;
Knowledge Harvest;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Regulatory Submission Support for novel methodologies.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Bioequivalence studies (Pharma generics)

Study Design;
Benefit-risk assessment (support);
Comparison of the bioavailability;
Perform comparability studies such as pharmacokinetic (PK), pharma-codynamic (PD) and dissolution profiles.

4TE Consulting | Research & Development

Process Development Acceleration;
QTPP (Quality Target Product Profile);
CQA definition;
Risk Assessment Studies;
Design Space Definition;
Data-Driven Analysis: Use of QbD tools (MVDA, DoE, PAT);
Control Strategy Development;
Check Points / Gap Analysis (Process & Product Understanding);
Scale-Up/Scale-Down Qualified Models;
Tech transfer – from R&D to pilot scale;
CMC Studies;
Support in Formulation, Manufacturing process and analytical methods development;
Strategic Advising on BAT (Best Available Technologies);
Biosimilarity and Bioequivalence comparability studies;
Knowledge Harvest;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control);
Regulatory Submission Support for novel methodologies.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Supply Chain

Raw-Material Characterization;
Counterfeiting Detection Solutions;
Suppliers’ Risk Assessment.
Support suppliers’ Qualification.

4TE Consulting | Supply Chain

Raw-Material Real Time Release;
Counterfeiting Detection for feed stocks and commercial products; • Suppliers’ Risk and lifecycle management;
Support Suppliers’ Qualification.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | Risk Register

RISK REGISTER is an integrated and simple solution to QRM which allows for a streamlined environment where strategic risks are filled, managed and analyzed, while ensuring that risk mitigation actions are focused on the most significant threats to the business.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Continued Process VeriFIcation (CPV) / On-going Process VeriFIcation (OPV)

Establishment of a CPV/OPV plan;
Continuous process risk assessment;
Continual assurance that the process remains in a state of control.

4TE Consulting | INDUSTRIALIZATION

Risk based CQV;
Risk Assessment studies;
Process Robustness Screening;
Control Strategy Definition;
Qualification Plan;
Process Performance Qualification (PPQ) activities support;
Scale-up/tech transfer to commercial scale;
Tech Transfer from sponsors to CDMO (risk-based assessment and KPI definition);
Analytical package support (PAT, IPC, release methods);
Strategic Advising on BAT (Best Available Technologies);
QMS Gap assessment (ICH Q8 thr Q14) and SOP revision;
Gap Analysis and Process improvement support;
CSV support;
Regulatory Submission Support;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support;
Batch and Continuous manufacturing (PAT and supervisory control).

4TE Consulting | COMMERCIAL OPERATIONS

E2E Process lifecycle management;
Risk Assessment studies;
Site Transfer support;
Comparability Studies;
Process Scale Transfers Support (Up or Down);
Data-driven troubleshooting;
Knowledge/ Portfolio Management;
Control Strategy verification;
Multivariate Condition Monitoring;
Integration of Process Analytical Technologies (PAT);
Continued Process Verification (CPV) / On-going Process Verification (OPV) ;
Reformulation and Process optimization support;
Product Quality Review (PQR) support;
Retrospective QbD implementation for legacy products;
Post-approval Change Management & Submissions;
Audit Support;
Digital Twins/ Predictive analytics and modeling;
Root Cause Analysis;
CSV support;
Roadmap and tools for digitization;
Custom made digital solutions;
Process intensification support.

Product | iRISK™

iRISK™ is an integrated solution adaptable to every QRM need in a collaborative cloud-based-platform suited for the industry 4.0, where you can have a standardized Quality Risk Management, give your inputs directly through the platform and following a QbD approach.

Identify, quantify and prioritize risks related to products, equipment validation, suppliers, facilities or analytical methods, among others, in a user-friendly manner and using several QRM tools;
Formulate risk mitigation strategies over lifecycle and build your own control strategy;
Improve your risk-based decisions comparing risk profiles from multiple strategies;
Aggregate knowledge across different lifecycle stages or multiple projects, reducing the knowledge gaps and breaking silos;
Save time building reports;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Product | iSEE™

iSEE™ provides all aspects of 4.0 Process Development and Lifecycle Management under one-environment, allowing for models and algorithms to turn your data into useful information.

Drive horizontal integration (process analysis, from end-to-end) and vertical integration (historical aggregation for lifecycle management) with iSEETM and its modules;
Use robust Data-Science and Risk-based approaches, decisions convert into actions;
Optimize your CPV and assure continuous improvement;
Use knowledge-based search engine for all the explicit and tacit knowledge acquired throughout the product lifecycle;
Save time building automatic reports;
Perform a comparability exercise in your Biosimilarity assessments, Scale-up operations and changes over lifecycle, using both traditional and innovative approaches;
Have a solid track of any alteration or action taken through an Audit trail, for a more streamlined discussion with regulatory authorities.

Our Lifecycle

Our Solutions

Quality Risk Management Digitalization

Quality Risk Management Optimization

End-to-End Lifecycle Management

Process Scale-up Strategy and Implementation

Quality by Design Frameworks

Root-Cause Analysis and Corrective and Preventive Action

Pharma Software designed for you