Regulatory Affairs Services

Streamline your regulatory processes with our expert solutions, tailored to ensure compliance and smooth market access. We specialise in:

• Product Licensing (Preparation and submissions of eCTD files)
  • Prescription Only Medicines (POM), Pharmacy Medicines (P), General Sales List (GSL), and Traditional Herbal Registrations (THR).
  • National, Mutual Recognition Procedure (MRP), and Decentralised Procedure (DCP).
  • New product licences, line extensions, and variations (e.g., indication changes/extensions, well-established use, category switches).
• Packaging and Artwork Services: Design and content development for packaging artwork and box layouts.
• NHSBSA and DHSC submissions: Facilitate clients to get their products listed and approved with key stakeholder including NHSBSA, DHSC, and wholesalers.