Regulatory Affairs (RA)

Our Consulting Services include

  1. Regulatory Strategies for Fastracking Market Approvals, Reducing Costs & Furthering Product Innovation
  2. Liaison with Regulatory Agencies like Health Canada, US FDA and EU's EMA, for example, in pre-submission meetings
  3. Chemistry, Manufacturing & Controls (CMC)
  4. Label Compliance for Drugs, NHPs, Medical Devices and Cosmetics, which are often part of
  5. Regulatory Submissions / Filings to Regulatory Agencies 

Regulatory Submissions / Filings

Human Use Pharmaceuticals, Generics, Biologics, Biosimilars & Radiopharmaceuticals, Veterinary Drugs

Drug Master Files (DMF)

Pre-market Clinical / Investigational (e.g. CTA, IND, INAD)

Product Market Authorization (e.g. NDS, NDA, BLA, ANDS, ANDA, DIN, MAA, NADA)

Post Market Product / Site Changes (e.g. SNDS, SANDS, NC, PAS, CBE-30, CBE, Type IA / IB, II Variations, Extensions)

Drug Establishment Licensing (DEL), Amendments, Annual Reviews

Natural Health Products (NHP), Dietary Supplements, Dietary Ingredients, Over The Counter (OTC) Non-Prescription Drugs

Clinical Trial Applications

NHP Master Files (NHP-MF)

Product Licensing (e.g. PLA, NDA, ANDA, TEA)

Site Licensing (SLA) & Renewals

Post Market Changes (e.g. Notifications, Amendments, Site License Renewals)

New Dietary Ingredient Notifications (NDIN)

Health Claim Petitions

Qualified Health Claim Petitions

Structure Function Claim Notifications

Nutrient Content Claim Notifications

 

Webinar(s):

 

FDA vs. Health Canada

Medical Devices

Pre-Market Investigational (e.g. ITA, IDE)

Product Market Authorization (e.g. Class II, III, IV Applications, 510(k), PMA, Technical File, CE Marking)

Post Market Changes (e.g. License Amendments, PMA Supplements)

Medical Device Establishment Licensing (MDEL), Facility Registration & Listing

Cosmetics

Cosmetic Notifications (CNF)