New Product Support

In the complex and increasingly regulated pharmaceutical industry, Regulatory Compliance Associates^® (RCA) 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.

• Global Regulatory Strategy
  • Regulatory Strategy
  • Establishment Registration
  • Follow-up and Question Resolution
• 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)
  • Orphan Designation (Formal Designation Request)

• Authoring, Review and Submission, including:
  • Investigational New Drug Applications (INDs)
  • 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
• 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