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.