Regulatory/QA
Regulatory Affairs Consulting
With decades of experience in the areas of Canadian and US regulations we can:
- Negotiate with Government Regulatory Agencies including the TPD, FDA and EMEA.
- Prepare drug submissions, device applications and establishment establishment license applications.
- Prepare natural health product license applications and natural health product site license applications.
- Review drug, food, cosmetic and natural health product labelling for regulatory compliance.
- Assist in the completion of the cosmetic notification form.
We are continuously retraining to keep current with the changing demands of the Regulatory Authorities.
Quality Assurance
We provide quality control evaluation and consultation for your product. This includes:
- Manufacturing facility assessment and on site product inspection.
- Conformity testing and quality control in pharmaceuticals, natural health products, and cosmetics.
- Ensuring regulatory compliance for GMP documentation.
- Conformity testing of metals and alloys.
- Quality control of fuels for airports, municipalities and industry.
