Medical Cannabis Risk Assessment & Management

The pharmacology of cannabis is complex due to specific risks related to the wide range of naturally occurring compounds.

As the industry evolves, it is expected that GMP compliance and certification will become the standard similarly to the food and pharmaceutical sectors.

However, having a complete understanding of existing regulations (regional and global) and business risks involved in obtaining GMP certification can be challenging.

To help you with this, 4TE provides our expertise in Quality Risk Management (QRM) built on top of our Consultancy services and QRM digital platforms.


Talk to our team

CBD Digital Risk Management

The pharmacology of cannabis is complex due to specific risks related to the wide range of naturally occurring compounds.

As the industry evolves, it is expected that GMP compliance and certification will become the standard similarly to the food and pharmaceutical sectors. However, having a complete understanding of existing regulations (regional and global) and business risks involved in obtaining GMP certification can be challenging.

To help you with this, 4TE provides our expertise in Quality Risk Management (QRM) built on top of our Consultancy services and QRM digital platforms.


Talk to our team

Full awareness of applicable regulatory framework

Gap assessment in infrastructure and quality management systems requirements

Equipment, systems and software qualification and process qualification

Preparation for licensing audits and inspections based on GMP and GACP

Tools and methodologies to minimize non-conformity risks

How to de-risk CBD manufacturing?

Having a structured risk management framework is essential in the Medical Cannabis industry. Yet, it is one of the challenges faced by professionals working in this industry today, mainly due to the lack of knowledge and standardisation in pursuing a QRM approach.

A well-defined, science-based QRM allows to be better prepared for audits and GACP / GMP licensing, inspections, and thus efficiently get the necessary permissions from the regulatory agencies.

Having the knowledge of the regulatory framework, the processes/product characteristics, and the principles of risk, and binding them all together with the proper digital platforms can yield large rewards in efficiency and revenue.

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Take a step ahead of competitors

4TE can support you by setting up such processes and strategies.

Our solutions will help you identify, quantify, and prioritize risks from seed-to-sale. You will be able to build Risk Mitigation Strategies for both new and existing assets over the lifecycle of Products, Equipment, Suppliers, Facilities and Analytical Methods.

We bring to the Cannabis Industry the learnings we have acquired and the technology we developed for the Pharmaceutical Industry throughout almost two decades.

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Working with us will bring you a step ahead of everyone

Our QRM expertise and methodologies can leverage your Medical Cannabis business by providing:

  • An accurate risk and process history based on one of the best Risk Management platforms
  • A full mapping of the risks associated to Medical Cannabis production
  • Defining and implementing a monitoring and control plan to make sure risks do not escalate
  • Implementing control strategies to support risk mitigation throughout the product lifecycle
  • State-of-the-art procedures for swift Quality Risk Management Assessment
  • Data connected and compared across your whole organization, not just your facility or department
  • Absolute control over the creation of your Risk Management workflows, supported by templates to assure consistency
  • Tools to make informed choices about compared risks and a solid basis to support your decision-making process

The solutions we work with

consulting irisk riskregister isee

What can you expect when you work with us

  • We will have a Pre-project meeting so that we can understand your expectations in the short and medium-term.
  • When everything is lined-up, and if you are happy, we will enter into contract.
  • Our teams will meet to formalize the project kick-off, covering the project scope, schedule, milestones, deliverables, and anything else that is necessary.
  • We will install any necessary software that we may have agreed before.
  • If that's the case will define Software training dates for your team in order to make sure you can make the most out of Risk Management Digitalization.
  • We will provide you support and follow-up during our partnership.
software-print

Time to upgrade your Medical Cannabis quality risk management processes!