Services

design & consulting
  1. 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
  2. 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
  3. 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

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