Outsourcing & Regulatory Services
Expert guidance on CTD/eCTD submissions, pharmacovigilance, supply chain outsourcing, pilot batch production, stability studies, naming services, pricing negotiations, and risk management plan development — a full-service regulatory partner for the Egyptian and Arab pharmaceutical market.
Core Outsourcing Services
Pharmacovigilance Outsourcing
End-to-end PV outsourcing: ICSR handling, PSURs, RMPs, signal detection and a local QPPV liaison for the EDA and Arab regulators.
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eCTD / Regulatory Submission Outsourcing
Full eCTD dossier compilation, lifecycle management and agency submission, handled for you end to end.
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Registration Services
Full regulatory registration support for pharmaceutical drugs, veterinary drugs, and vitamins & supplements with the Egyptian MOH/EDA.
Contact usSupply Chain & Manufacturing Support
Supply Chain Outsourcing & Pilot Batch Production
We coordinate sourcing, manufacturing partners and pilot batch production runs so your product moves from formulation to registerable batch without you having to manage every vendor relationship directly.
Stability Studies
Design and follow-up of stability programs in line with ICH and EDA guidelines, supporting shelf-life claims for registration dossiers.
Regulatory Consulting
Naming services, pricing negotiations, and risk management plan (RMP) development — the regulatory and commercial groundwork that goes alongside a submission, handled by the same team managing your dossier.