- 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 strategy design and implementation.
- End to end support from the manufacturer to the end consumer.
- Management of mega regulatory projects (Mergers & Acquisitions, licensing, manufacturing, tech transfer, creation of drug dossiers).
- New registrations (Human Drug, biological, biosimilar, Herbals, Medical Device, Cosmetics, and Food Supplements).
- Local serialization and aggregation.
- Life Cycle Management (Variations/renewals).
- Products classification.
- Compliance review and creation of SPCs, leaflets (PIL), labels, and artworks.
Technical Writing & Publishing
- CMC technical writing.
- eCTD compilation.
- 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) Compliance with SFDA.
- Pharmacovigilance Audit