- CO2 Extraction
- Ethanol Extraction
- Terpene Profiles
- Crude & Refined
All products fall into one regulatory category or another. We can ensure that your product is complaint from choosing ingredients, to assessing formulation viability and format compliance to label claims and standards. We are regulatory experts in cannabis products, natural health products, novel foods, supplemented foods, conventional foods, cosmetics, veterinary health products and more.
Product quality has become a key factor for regulators and brand holders are responsible for ensuring that all products meet required and stated specifications. We can develop protocols for studies, create specifications, certificate of analysis and translate lab data.
Quality is key for all facilities and whether you are a cannabis cultivator or processor, a manufacturer, packager, labeler or importer for natural health products of a food establishment we can assist in you site compliance activates. We can assist and instigate several quality standards such as GPP, GACP, GMP, EU GMP, TGA, ISO and PICS compliance as well as set up change management and internal audits. Unlike other consultants we assist with all facets of regulatory compliance and will ensure that we are involved from site specifications, regulatory submissions, development of SOPs and ongoing GMP training.
Cannabis sites at a minimum need to be complainant to Health Canadas Good Production Practices, however many stakeholders are seeing the benefit of meeting higher standards, e.g. Good Agricultural and Growth Practices and EU GMP. Either way we can see you through the compliance and set up a vigorous quality plan that can surpass regulatory expectations. With a variety of different dosage format types permissible in the cannabis space we can also help with GMP standards for these using lean manufacturing principles, globally recognized practices and principles from the Safe Foods for Canadians act. As there are many stipulations for facilities, we can assist from the ground up and engage with contractors and other third parties involved in the project.
Manufacturing, packaging, labelling and importation of Natural Health Products requires a site license that is reviewed and approved by the Natural and Non-Prescription Health Products Directorate. We can not only help with completed the Quality Assurance Report and licensing process but also ensure that the site is functioning at GMP standards. We can also trigger the renewal process and ensure that the site is on track for annual review. Natural Health Products can be made by foreign sites that can either be registered with Health Canada or can provide additional evidence in several forms, this can also be assessed and managed by our team.
Regardless of whether your product is a natural health product, a food or a cannabis edible any claims regardless of how benign they may seem must not be misleading. When developing products many factors need to be considered to ensure that the product can be commercialized, this begins with whether it is compliant within its product category.
Let us make sure your concept is headed down the right track. There are several activates that we can undertake to make to ensure that your product is compliant to the market you are trying to enter.
Not all ingredients are permitted in all products and depending on ingredients and dosage format the product category may not be accurate. We can assess the ingredients, formulation and intended dosage format and advice on next steps.
If you are making a Natural Health Product and want to ensure that you can get the claim that you would like we can complete an evidence assessment before you go down the road of formulation research and development.
Pacific Rim Innovations is a proponent of research partnerships with institutes and field experts and can help manage your research project by placing it in the right hands. We have devised a way of managing research and development projects between academic institutes and industry stakeholders that successfully communicates the requirements from all parties. We can manage a magnitude of studies including research and development, bioactivity assessment, bioavailability studies, animal studies, toxicological studies etc. We can translate the data and produce white papers or prepare peer-reviewed publications.