Regulatory Affairs Management

WE CAN DEFINE, MANAGE AND IMPLEMENT YOUR ENTIRE REGULATORY PROJECT

Regulatory Strategy

SEQ 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

SEQ 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. SEQ 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

SEQ 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).

  • Over the counter (OTC).

  • General Sale (GSL).

  • Herbal products.

  • Food supplements.

  • CE Marking.

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

For more information please contact us at: enquiries@nerin.co.im