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Pharmaceuticals & API

Regulatory Affairs Consulting

Don’t risk losing quality and trust: choose the right regulatory guidance, training and support. Turn compliance into a competitive advantage with scalable, cost-effective Regulatory Affairs solutions.

Services

    Regulatory Affairs
    (Sector - Pharmaceuticals)

  • Active Pharmaceutical Ingredients (API)
  • Intermediates
  • Regulatory Strategy Development and Advice as per current guidelines
  • Certificate of Suitability (CEPs)
  • Open & Closed Part Preparation
  • Regulatory Submission support
  • Region-Specific Regulatory Filings (US, Europe, Brazil, China, Japan, other markets)
  • Drug Master File (DMF) Preparation & Filing
  • Common Technical Document (CTD) Dossiers
  • Technical data package
  • Technical Q&A / Deficiency Response Handling

    Change Management

  • Evaluation and Impact assessment for Change Control
  • Evaluation of category of change and support for Variations/ Amendment filing as required (Major, Minor, Annual, Notification/ Type Ia, Type Ib, Type II/ CBE 0, CBE 30, PAS)

    Additional Services

  • Vendor Assessment with respect to DMF filing
  • Strategic evaluation for route of synthesis (ROS) and filing strategy
  • Impurities assessment: Genotoxic, Nitrosamine and other

    Regulatory Assistant Services

  • SPOR database - Europe
  • DUNS
  • FDA CDER next gen portal
  • Facility Establishment Registration
  • Drug Listing
  • ANVISA

    Quality Service

  • Designing of Quality procedures
  • Designing of Site Master file as per PICs,WHO,EU and Schedule M
  • Designing of Risk Assessment Procedures
  • Compliance evaluation
  • Audit support

    Training

  • ICH Guidelines
  • cGMP requirements
  • ALCOA++
  • Data Integrity
  • Regulatory Expectations and requirements
  • Regulatory Updates
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