Putting Science to Work
Regulatory_Filing

Regulatory Filing

Syngene has capabilities to support clients in:

  • Regulatory strategy, scientific dossier preparation, dossier publishing, submission to the regulatory agencies, supporting in queries and managing product life cycle.
  • Regulatory support for development of new chemical entities, biologics and biosimilars in early and late development stages for US, EU, Japan and Emerging Markets.
  • Authoring dossiers in CTD/ACTD/country specific formats, and can publish in eCTD/NeeS/Paper formats.
  • Filing/authoring of USDMFs (Type II to V), EU-ASMF, JDMF and CEP.
  • Documentation for Scientific advises, Type A-C meetings, End of Phase 2 meetings, Controlled correspondence.

We have been a partner to our clients for various successful filings throughout their product lifecycle and have actively supported them in their integrated development program, realizing affordable innovation.

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