Regulatory Services

Due Diligence Audits

To help qualify your readiness to become a licensed producer, we provide routine and gap analysis audits of your Quality Systems and compliance action plans that prepare you for impending Health Canada or investor audits.

DIN/NHPs for Cannabis Products

The submission for registration of a cannabis designated drug information number (DIN) or cannabis based Natural Health Product (NHP) can be a complex process with many hurdles that could impact the registration timeline and cost. Q&C consultants are experts at navigating the Health Canada drug/NHP licensing process including collating required supporting documents and correctly filling out forms that proactively addresses Health Canada requirements. Q&C accelerates the learning process ensuring you have a fully compliant system with all procedures and supporting documents. Q&C ensures you have what you need and do not spend more than you have to in the registration process.

ACMPR Licensed Producer (LP) Application

The Access to Cannabis for Medical Purposes Regulation (ACMPR) is the set of enforced requirements for the facility and production of cannabis. Q&C helps our clients navigate the constantly evolving requirements to ensure a facility is ready to produce and distribute cannabis and cannabis related products. Our clients' applications have been approved with minimal Health Canada questions and red flags. Once again, Q&C ensures you have what you need for the approval process and you do not spend more than necessary over qualifying.

ACMPR Licensed Dealer Applications

Health Canada’s Office of Controlled Substances (OCS) requires a drafted Dealer’s Licence application supported by detailed documentation of the applicant’s related personnel, proposed site, security measures at the premises, recording of drug transactions and others purposed activities (i.e. Research Development (R & D), Analytical testing and conducting Clinical studies). Q&C will help prepare and assemble this thorough application so that all expectations are met.

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/understanding-new-access-to- cannabis-for-medical-purposes-regulations.html

ACMPR Quality Assurance Report

The ACMPR Quality Assurance Report (QAR) is a key component of the ACMPR Licensed Producer application. Often 40+ pages, the QAR includes required specifications (e.g. testing and acceptance requirements) and summarizes the expectations of Health Canada depending on the dosage forms. It also includes all activities that you will be performing at your facility (e.g. destruction of unsaleable material). The QAR has a designated Quality Assurance Person (QAP) which Q&C can be for a client, temporarily or full time.

Many clients struggle with the growing licensing, regulations and ongoing traceable documentation requirements. Q&C ensures our clients are current and compliant with the regulations. Q&C has been working with pharmaceutical clients for over twenty years and has in depth experience and relationships with Health Canada.

Business Plans

As part of the ACMPR application process, Health Canada’s requires assurance that an applicant’s business has a good chance of success, so having a robust business plan is crucial. Q&C’s team of expert consultants help our clients develop and build solid plans based on thorough research and sound data analysis to ensure financing and investment is secured and the business is primed for profitability.