Regulatory Affairs

Regulatory Affairs

It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and its extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions.

  • We provide Technical Support in the below mentioned Areas:
  • Preparation of Drug Substance and Drug product registration dossier
  • Dossier Preparation & Submissions Support in CTD [(Electronic Common Technical Document (drug registration)] / eCTD, ACTD [Asian Common Technical Dossier]
  • NeeS [Non-eCTD electronic Submissions (NeeS)] formats to different Health Authorities of Regulated and Semi-Regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO
  • Drug Firm Establishment Registration with US-FDA [United States’ Food and Drug Administration] (FEI [Facility Establishment Identifier])
  • Drug Listing in SPL [Structured Product labelling] format, Bulk Drug Listing
  • NDC [National Drug Code] and Electronic submission
  • Preparation of DMF [Drug Master Files]/ ASMF [Active Substance Master File] / CEP [Certificate of Suitability] or (CoS) / KDMF/ Technical Packages
  • Site Master file as per PIC/s & Local FDA requirement