OUR SERVICES

Regulatory Affairs

Regulatory strategy development.
Management of 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), label, 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.

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.

Technical Writing & Publishing

CMC technical writing.
eCTD compilation.

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