25+ years of Regulatory Affairs and Compliance experience. Product development, submission preparation, filing, follow-up/negotiation with authorities, post-approval commitments/maintenance. Baseline assessments, due diligence, gap analyses. Regulatory Affairs training courses. Audit readiness/enforcement. CAPA Management/Effectiveness Monitoring. Pharmacovigilance support.

Product Areas

Innovative drugs
Generic drugs
Biologics/biotechnology
Active Pharmaceutical Ingredients
Subsequent entry biologics
Cosmetics
Medical devices
Natural health products
OTC/non-prescription drugs
Drug/device combination products
CBD Industry
Veterinary
Radiopharmaceuticals
Other

Jurisdictions

Canada
US
Europe (EU)
Non-EU Europe
Asia
Australia / New Zealand
Latin America
Worldwide

Pharmakon, in Ancient Greek philosophy and critical theory, is a composite of three meanings: remedy, poison, and scapegoat. Contact us and let us help you choose the right meaning.