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Services

Qualified Person

  • Batch release according national regulations for human pharmaceutical medicinal products in development and already registered
    •     - Review of batch manufacturing documentation
        - Review of batch analytical documentation
        - Batch Release Certificate
  • QP declaration for equivalence to EU-GMP for IMPs manufactured in third countries

    • GMP Related Activities

  • Site audits including audit report
  • Support in GMP-improvement
  • Support in implementation of Inspection-findings
    •     -Activity plan
        -Supervision of activity plan
  • SOP
    •     - Review
        - Development
  • Change control
    •     - Supervision in activities

    Regulatory Affairs

  • Guidance in EU-Regulatory System
  • Guidance in Dossier development
  • Control of Dossiers for IMP’s and for marketing authorisation submission
  • Guidance in variations

    • Industrial Manager

    Empowerment for the representation of a pharmaceutical company in front of regulatory authorities.

    Why Choosing Me?

    The combination of 30-years world-wide regulatory affairs, 15-years activity as Qualified Person for registered drugs and Investigational New Products, 6-years in manufacturing and control for biological and biotechnological medicinal products and support in pharmacovigilance, development, change control and agencies-presentations gives a unique profile in flexibility and efficiency.

    Contact me