Regulatory Affairs (RA)
Our Consulting Services include
- Regulatory Strategies for Fastracking Market Approvals, Reducing Costs & Furthering Product Innovation
- Liaison with Regulatory Agencies like Health Canada, US FDA and EU's EMA, for example, in pre-submission meetings
- Chemistry, Manufacturing & Controls (CMC)
- Label Compliance for Drugs, NHPs, Medical Devices and Cosmetics, which are often part of
- 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
Article(s):
NHPs - Effective Regulatory Navigation & Strategies for Cost-Time Savings & Product Innovation
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
Article(s):
FDA Efforts to Regulate Innovative Technologies & Facilitate Market Access
FDA Regulation & Advancements in Medical Device Technologies
Webinar(s):
FDA Regulation, 3D Printing & Medical Devices
Use of Electronic Health Records (EHR) in FDA Regulated Clinical Investigations
Cosmetics
Cosmetic Notifications (CNF)
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Copyright [since 2014/2015] by regulatoryheights.com / Regulatory Heights Inc.
Copyright [since 2014/2015] by regulatoryheights.com / Regulatory Heights Inc.