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An IS0 9001:2015 Certified Institute

Regulatory Strategy & Reports

Introduction

A perfectly well planned regulatory strategy is very important to get out of hurdles on non-compliance to regulatory. We at Maven give end to end regulatory strategy for your product to pass in regulatory and market your products with ease. Our esteemed services are not only to US and EU but to the ROW markets as wells.

STRATEGIES& CONCLUSION

  • Developing and executing global and regional strategy and contingencies for clients in all phases of development
    • Serve as primary interface for FDA
    • Lead teams in global Health Authority Meetings (FDA, EMA)
      • Client representation at meetings with Health Authorities
      • Team preparation for meetings with Health Authorities
      • Responses to FDA/foreign health authority requests for information
      • Acting US Agent for foreign sponsors
    • Preparation of initial applications and amendments for INDs, CTAs, NDAs, BLAs and MAAs
    • IND/CTA and marketing application maintenance including annual reports, DSUR, PSUR, PADER, PBRER
    • Preparation of Product Development Plans
    • Acting head of Regulatory Affairs for start-up companies
    • Preparation of product labeling