Hay Pharma ConsultingLaval, Quebec
- Analytical method development and validation / compliance; - API regulation and suppliers; - Certificate of a Pharmaceutical Product (CPP); - Chemistry (any aspect of chemistry in general); - CMC regulatory compliance; - Drug Substance, Drug Product and excipient specifications creation and review; - Establishment Licences (Drugs, Medical Devices); - Generic injectable product development from A to Z; - Pharmacovigilance support / implementation; - Post-market & Life-cycle management; - Recall management; - Regulatory strategic plan and compliance; - Regulatory submission preparation (ANDS, SANDS, DINA); - Sterile formulation and lab-scale batch support; - Technological transfer / Product in-Licensing / Dossier compliance; - Technical writing.
- Generic drugs
- Active Pharmaceutical Ingredients
- Europe (EU)
- Australia / New Zealand