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.

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.

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.
iocenters, conference room, meeting room

Stages to Approval

We like to simplify our work process for our clients into the following three stages. Each with critical importance that requires accurate analysis and multiple runs into previous experience repository to ensure flawless operation.

01. Gap Analysis

A process where entities and product files goes into scrutinization against regulations and legal requirments.

02. Compilation

Files of each submission type is with different compilation requirements whether electronic, semi-electronic, or paper-based.

03. Submission

The step where the product file is officially at the authorities end for evaluation. 

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