Drugs
In Canada, drugs range from simple topical creams to complex prescription drugs. This category includes products considered cosmetics in some markets, such as SPF products. Prescription creams to complex prescription aspects of scientific and regulatory affairs, manufacturing, and here are some ways we can help:
Regulatory Affairs
- Correctly classify a product – Drug, Natural Health Product, Cosmetic, or Food
- Prepare applications for product approval
- Assist with product importation to Canada (Drug Identification Number – DIN)
- Manage post-approval changes such as product reformulation or new labeling
- Prepare applications for the approval of manufacturing, packaging, and warehousing facilities (Drug Establishment Licenses)
Labeling and Marketing Compliance
- Reviews of product labels, inserts, print and broadcast advertising
Environmental Compliance
- Review ingredients for compliance with the Canadian Environmental Protection Act (CEPA)
- Complete submissions to Environment Canada
Quality Assurance
- Conduct Drug GMP audits and host inspections from Health Canada
- Prepare and review Standard Operating Practices (SOPs)
- Manage consumer complaints and Adverse Drug Reactions (ADRs)
- Act as Canadian QA to release product for shipment into Canada
Scientific Affairs
- Design and commission stability studies
- Prepare finished product specifications
- Provide assistance with analytical test methods
- Evaluate product/package compatibility
- Design and commission clinical trials
Due Diligence
- Analyze all technical and scientific aspects of products
Consumer Research
- design and conduct concept and product acceptance tests
- Interpret existing research data
- Conduct focus groups
Claim Substantiation
- Design and commission studies pertaining to product performance
- Review existing clinical or scientific data in support of packaging or advertising claims