Regulatory Affairs Management


Regulatory Strategy

Pharmafile are able to help reduce your ‘time-to-market’ by designing a practical regulatory strategy, linking into development plans according to individual client needs:

  • Develop and implement rational regulatory strategies

  • Advise on requirements and provide opinion for regulatory submissions/approvals

  • Perform benefit/risk analysis of options for regulatory compliance.

Regulatory Submission Management

Pharmafile associates have extensive experience in the pre-submission preparation, submission and lifecycle management of EU Marketing Authorisations, providing full technical and regulatory due diligence on Product Dossiers planned for registration and subsequent marketing. Pharmafile use the advanced submission Management System (docuBridge) for eCTD and lifecycle management for National and European (CP, DCP, MRP) procedures including renewals, variations and other post approval maintenance activities.

Regulatory Achievements

Pharmafile has successfully managed a diverse range of regulatory projects for the majority of the therapeutic areas across the full range of dosage forms; capsules, tablets, injection, infusion, topical, eye drops, etc…

  • Prescription only medicines (POM), solid dose, topical, powders

  • Pharmacy (P)

  • General Sale (GSL)

  • Herbal products

  • Food supplements

  • Over the counter (OTC)

  • CE Marking

Pharmafile has achieved more than 1000 product approvals through National, MR and DC procedures across Europe.

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