SERVICES

Regulatory Compliance Support

Strategic Services

  • Strategic assistance in Pharma Regulatory filing
  • Support in Outsourcing Manufacturing or Testing Laboratories for Clients
  • Support in Outsourcing BA/BE study centers
  • Liaison for DCGI licensing & FDA, CDSCO activities

Advisory Services

  • cGMP (current Good Manufacturing Practice) compliance
  • Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs
  • Compliance audits as per current and updated statutory pharma regulations
  • Critical Review of Dossiers
  • GAP Analysis/Due diligence
  • Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms

Technical Assistance

  • Preparation of Drug Substance and Drug product registration dossier
  • Dossier Preparation & Submissions 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 labeling] 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