Our Services

Consultation

  • New access to the Saudi market.
  • Drug price evaluation and SFDA appeals.
  • Representations and Meetings with the authorities.
  • Manufacturing and tech transfer.
  • Distributor search and contracting.
  • Patent related consultations.

Regulatory Affairs

  • Regulatory strategy development.
  • Managing mega regulatory projects (Mergers & Acquisitions, licensing, manufacturing).
  • End to end roadmap design from the manufacturer to the end consumer.
  • New registrations (Drug, Veterinary, Herbal, Medical Device, Cosmetics, Supplements).
  • Local serialization and aggregation.
  • Life Cycle Management (Variations/renewals).
  • Products classification.
  • Creation and compliance review of SPC, leaflets (PIL), labels, and artworks.

Pharmacovigilance

  • Full outsource services for Pharmacovigilance compliance.
  • QPPV services
  • Building PV systems and documentation (PSMF, PSSF, RMP, PSUR/PEBRER, PV SOPs).
  • PV literature review in Saudi journals.
  • E2C (R2) Compliant with SFDA.

Technical Writing & Publishing

  • CMC technical writing.
  • eCTD compilation.