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Drugs

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Drug Product Regulation

I Will be Your Personal Assistant to Drug Product Regulation

As a Ph.D. Chemist and Regulatory Specialist (7+ Years), I specialize in Drug Product regulation. I will help you Streamline Your Marketing Authorization Applications for FDA, EMA & MHRA.

Avoid costly delays, or RTR! and save up to 70% in the journey of your drug regulation.

 

Why Choose Me?

  • ️7+ Years in Regulatory Affairs Successfully filed 24+ MAAs.
  • Chemistry Manufacturing and Control (CMC) expert.
  • Provide complete strategy for your drug product.
  • eCTD gap analysis and provide guidance to avoid RTR
  • 100% Confidentiality Signed NDAs.
  • DS & DP documents
  • Provide updated FDA, EMA and MHRA guideline.
  • FDA
  • MHRA
  • EMA
  • IND, NDA & ANDA (abbreviated new drug application)
  • eCTD (Electronic Common Technical Document)
  • Generic & Hybrid application
  • CMC
  • Clinical, non-clinical summary

ANDA & Generic Applications

ANDA (505(j)) and hybrid applications, including drafting Modules 1-5.

CMC Documentation

Chemistry, Manufacturing, and Control (CMC) sections for Drug Substance (DS), Drug Product (DP), and Drug Device Combinations (DDC).

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We Will be Your Personal Assistant to Your Drug Product Regulation

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