Regulatory Affairs

Our regulatory officers are experts in dealing with different regulatory bodies globally

Regulatory Affairs

Our regulatory officers are experts in dealing with different regulatory bodies globally. We ensure successful dossier submissions within committed timelines. Our clear understanding on guidelines, review process and exposure to multiple regulatories assists to get early approvals.

Our outstanding experience in CROs gives guidance and offer services in preparation of response to various regulatory observations from audits and inspections. We deal with regulatory agencies like US FDA, EMEA, UK MHRA, ANVISA, TGA and others…

Regulatory services include :

  • Drug master file and submission (DMF)
  • Preparation of site master files (SMF)
  • Dossier preparation and submission to EMEA and USFDA
  • Applying NOC from DCGI
  • Answering to various regulatory findings