Our services

Regulatory Affairs Consulting

New Drug Application – NDA / BLA

  • Form FDA 356h Review
  • Form FDA 3397 Review
  • Form FDA 3331 Review
  • Cover Letter Review
  • Patent Information and Certification Review
  • Table of Content Review
  • Summary of Application Review
  • Chemistry Manufacturing and Controls Content Review
  • Non-clinical, toxicology and pharmacology data and summaries Review
  • Human Pharmacokinetics and Bioavailability Review
  • Microbiology Report Review
  • Clinical Data Review
  • Statistical Data Review
  • Case report forms and tabulations Review
  • Labeling Proposal Review
  • Patent Information Review
  • Financial disclosure Review

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