Regulatory And Research Services for Jordan
🇯🇴 Regulatory and Research Services for Jordan – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing comprehensive regulatory and research solutions for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Jordan market.
Our services ensure full compliance with the Jordan Food and Drug Administration (JFDA) regulations, as well as ICH, WHO, and ASEAN guidelines.
📘 Regulatory Services for Jordan
Regulatory & Product Registration Support – Jordan
We assist pharmaceutical, nutraceutical, and cosmetic companies through every stage of regulatory submission and product approval in Jordan, ensuring smooth market entry and full compliance with JFDA requirements.
📘 Product Registration Services
• Preparation and submission of registration dossiers for Rx and OTC products.
• Registration support for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets as per JFDA regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Jordan.
• Support in preparation of quality, safety, and stability data in line with JFDA and ICH guidelines.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in JFDA-approved CROs.
• Preparation of BE study reports compliant with WHO and JFDA standards.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods per ICH Q2(R2) guidelines.
• Preparation of AMV protocols and reports for regulatory submission and QC support.
🧾 Regulatory Consultancy & Compliance
• Comprehensive regulatory guidance for Jordan market entry or export compliance.
• Support for import/export permissions, JFDA inspections, and post-approval maintenance.
• Regular updates on JFDA regulatory changes to ensure continuous compliance.
🧪 Research & Development (R&D) Services – Jordan
Our R&D services support product development, validation, and quality assurance in alignment with JFDA and global standards.
💊 Formulation Development
• Development of solid, liquid, and semi-solid dosage forms.
• Optimization for stability, bioavailability, and performance under Jordanian climatic conditions.
🧫 Analytical R&D Services
• Analytical method development, assay, dissolution, and stability studies.
• Transfer and validation of methods for regulatory and QC purposes.
📑 Product Development Reports (PDRs)
• Preparation of detailed PDRs for regulatory submission to JFDA.
• Inclusion of formulation, process, and analytical validation data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical protocols, summary reports, and study dossiers for JFDA submission.
• Toxicology and preclinical study documentation as per OECD and WHO standards.
🌏 Why Choose Us for the Jordan Market
• Experienced Regulatory Experts – Specialized in JFDA, ICH, and WHO frameworks.
• Comprehensive Solutions – From dossier preparation to post-approval lifecycle management.
• Global & Regional Experience – Proven expertise across MENA, ASEAN, and EU markets.
• Efficient Documentation – Fast-track CTD/ACTD submissions ensuring quicker approvals.
• Customized Strategies – Tailored for each product category and regulatory pathway.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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