Regulatory
JHP has an experienced in-house Regulatory Affairs department capable of assisting you with Clinical Trial Applications (IND/CTA), New Drug Submissions (NDA/BLA/ANDA), and Supplements (PAS, Type I/II). Documentation can be provided in Common Technical Document (CTD) format to assist in expediting regulatory filings:

  • Facilitate Regulatory Strategy
  • Facilitate Interaction with Regulatory Authorities
  • Drug Master File
  • Guidance on Regulatory Submissions
  • Prepare Regulatory Documents
  • FDA, EMEA, PDMA, ANVISA, Health Canada

The Regulatory Affairs department is integrated into all product introduction activities and manufacturing changes that occur at the manufacturing facility (FDA Establishment License 1818977). It has an enviable track record in gaining approval of manufacturing site transfers and significant manufacturing initiatives. JHP’s Regulatory Affairs team is committed in providing assistance to our customers in Health Authority meetings, internal strategy discussions and submission preparation.

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