New capability, July 2026: PHARPRO has formalised a partnership with a specialised pharmaceutical registration company, enabling us to offer end-to-end drug registration services in Jordan, Syria, Lebanon, and across the GCC. One point of contact for your full compliance and registration needs.
For many pharmaceutical manufacturers and exporters, entering new markets in the Levant and GCC means navigating complex, country-specific regulatory requirements — each with its own dossier format, language requirements, timelines, and authority relationships. Missing a single requirement can delay approval by 12–18 months.
PHARPRO's registration partner brings deep, established relationships with JFDA (Jordan Food and Drug Administration), Syrian Ministry of Health, Lebanese Ministry of Public Health, SFDA (Saudi Food and Drug Authority), UAE Ministry of Health, and other GCC health authorities. Combined with PHARPRO's pharmaceutical quality and documentation expertise, this partnership delivers a complete, inspection-quality registration package.
What We Cover
CTD Dossier Preparation
Full ICH CTD-format dossier: Modules 1–5, CMC documentation, nonclinical summaries, clinical overviews.
Regulatory Submission
Direct submission to JFDA, SFDA, UAE MoH, Syrian MoH, Lebanese MoPH, and other GCC authorities.
Approval Tracking
Active follow-up with authorities, query responses, and status reporting throughout the review process.
Renewals & Variations
Licence renewals, post-approval variations, label updates, and manufacturer change notifications.
Multi-Country Strategy
Simultaneous or sequenced filings across multiple markets — coordinated submission strategy.
GMP Certificates & CPP
Certificate of Pharmaceutical Product (CPP) procurement and Good Manufacturing Practice certificate coordination.
Country-by-Country Registration Overview
| Country | Authority | Dossier Format | Typical Timeline |
|---|---|---|---|
| 🇯🇴 Jordan | JFDA | CTD / JFDA-specific | 12–24 months (new product) |
| 🇸🇾 Syria | Syrian Ministry of Health | National format | 18–30 months |
| 🇱🇧 Lebanon | Lebanese MoPH | CTD-based | 12–24 months |
| 🇸🇦 Saudi Arabia | SFDA | eCTD / CTD | 12–18 months (generics) |
| 🇦🇪 UAE | MoH UAE / MOHAP | CTD | 12–18 months |
| 🇰🇼 Kuwait | Ministry of Health | CTD-based | 18–24 months |
| 🇶🇦 Qatar | MOPH Qatar | CTD-based | 18–24 months |
Ready to register your product in Jordan or the GCC? Our team responds within one business day — submit your enquiry below.
Start Your Enquiry →Product Types We Handle
- Generic medicines — including bioequivalence documentation and comparative dissolution studies
- Branded innovator products — full CTD submission with clinical data modules
- OTC medicines — simplified registration pathways where applicable
- Dietary supplements & nutraceuticals — country-specific classification and filing
- Biologics & biosimilars — complex submissions with regulatory strategy support
- Medical devices (Class I/II) — where registration is handled alongside pharma submissions
Why Combine Registration with PHARPRO's GMP Expertise
Registration and GMP compliance are not separate processes — they are interdependent. Regulators in Jordan and the GCC routinely reject registration dossiers due to GMP deficiencies at the manufacturing site. Having PHARPRO's GMP, QA, and validation expertise integrated with your registration process means:
- Your manufacturing site documentation (GMP certificates, site master file) is prepared to the authority's exact expectations
- Quality deficiencies are identified and corrected before dossier submission — not after rejection
- Inspection readiness is built into the registration timeline, not bolted on as a reaction
- A single, accountable team handles your full compliance footprint across markets
خدمة تسجيل الأدوية — بالعربية
أبرمت PHARPRO شراكة مع شركة تسجيل متخصصة لتقديم خدمات تسجيل الأدوية في الأردن (هيئة الغذاء والدواء JFDA)، سوريا، لبنان، والمملكة العربية السعودية (SFDA)، والإمارات وبقية دول الخليج. نقدّم خدمات إعداد الملفات التسجيلية بتنسيق CTD، التقديم للجهات الرقابية، متابعة الاعتماد، التجديدات والتعديلات. للاستفسار: [email protected] أو واتساب +962 79 856 5807