In the complex and increasingly regulated pharmaceutical industry, Regulatory Compliance Associates® Inc. can assist you with new product development regulatory support. From early development stage and seeking guidance for FDA meetings, to later stage regulatory strategy and global alignment of submissions and dossiers, RCA is your one-stop source for regulatory expertise. We have over 500 global pharmaceutical consultants who provide services to support all types of new product applications.

RCA is your one-stop source for regulatory expertise.

Full Pharmaceutical New Product Development Regulatory Support

  • Global Regulatory Strategy
    • Regulatory Strategy for Drugs
    • Domestic and International Establishment Registration
    • Submission Authoring and Review, including:
      • New Drug Applications (NDAs)
      • Generic Drug Applications (ANDAs)
      • Drug Master Files (all types) (DMFs) and the European Pharmacopoeia and Certificates of Suitability (CEPs)
      • Marketing Authorization Application (MAA) Clinical Reviews
    • Follow-up and Question Resolution
    • Audit Support
  • Meetings and Briefings Packagers
    • Biologics License Application (BLA) Meetings
    • Type 8 Meetings
      • Pre-Investigational New Drug (Pre-IND)
      • End of Phase 2
      • Pre-New Drug Application (Pre-NDA)
    • Advisory Committee
    • Orphan Designation (Formal Designation Request)
  • Submissions
  • Drug Substance, Drug Product, Manufacturing, Labeling, Container Closure Supplier Requirements, Quality Assurance
  • Generic Drugs
  • Labeling for U.S. Submissions
    • Structured Product Labeling (SPL) Requirements and Analysis of Innovator Labeling
    • Side-by-Side Comparison
    • Assistance with “Carve-Outs” Related to Patents
      • SPL not Required at IND Phase has Nothing to do with SPL Labeling
  • NDA: 505(b)(1) & 505(b)(2) and NDAs

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