STARODUB

EXPERTS IN REGULATORY AFFAIRS

Strategic, Timely, Accurate, Regulatory Services To Every Client

Reliable

 

Efficient

 

Knowledgable


Our Services - Biotech/Biologics and Vaccines


We provide support for drug substance and drug products; original, biosimilar and orphan drugs.

Countries in scope


  • Worldwide

Regulatory CMC, pre-clinical and clinical support during development and lifecycle management


  • Regulatory strategy
  • Scientific advice meetings with Health Authorities
  • Dossier Due Diligence
  • Dossier maintenance / Lifecycle management
  • Authoring of CTD Modules and other required documents
  • Preparation and gathering of ancillary documents
  • Response to questions from Health Authorities
  • Labelling support and safety variations
  • Clinical trial applications, new submissions, variations, renewals and annual reports
  • Gap analysis and remediation packages for compliance activities and regulatory submissions

Areas of regulatory expertise


  • Drug substance process development:

    o Upstream processing

    o Downstream processing

  • TSE/BSE expertise
  • Viral safety
  • Pharmaceutical development

    o Parenteral preparations

    o New dosage forms / new strengths

  • Process validation
  • Sterilization process validation
  • Aseptic processing / media fills
  • Analytical development and validation
  • Stability testing
  • Comparability protocols / post approval change management protocols
  • Post-approval changes, e.g. changes in:

    o Manufacturing process

    o Manufacturing site

    o Facility

    o Analytical method and/or specification

    o Container closure system



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