Regulatory And Research Services for Libya
🇱🇾 Regulatory and Research Services for Libya – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research services for pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Libya market.
Our services ensure full compliance with the Libyan National Center for Drug Control & Research (NCDCR Libya), as well as WHO and ICH guidelines.
📘 Regulatory Services for Libya
Regulatory & Product Registration Support – Libya
We assist pharmaceutical, nutraceutical, and cosmetic companies in dossier preparation, submission, and product registration with NCDCR Libya, ensuring smooth market access and full regulatory compliance.
📘 Product Registration Services
• Preparation and submission of registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Traditional, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on labeling, packaging, and product information leaflets according to NCDCR Libya regulations.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for registration in Libya.
• Support in preparing quality, safety, and stability documentation in line with NCDCR Libya and ICH standards.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in NCDCR-approved CROs.
• Preparation of BE study protocols and reports according to WHO and NCDCR Libya requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods in compliance with ICH Q2(R2).
• Preparation of AMV documentation for regulatory submission and routine QC.
🧾 Regulatory Consultancy & Compliance
• Strategic regulatory guidance for entry into the Libya market.
• Assistance with import/export licensing, NCDCR Libya inspections, renewals, and post-approval compliance.
• Continuous updates on NCDCR Libya regulatory changes to ensure product compliance.
🧪 Research & Development (R&D) Services – Libya
Our R&D services support formulation development, analytical validation, and quality assurance activities in compliance with NCDCR Libya and international standards.
💊 Formulation Development
• Development and optimization of tablets, capsules, syrups, powders, and injectables.
• Stability studies designed for Libya’s climatic conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Analytical method development and transfer to partner laboratories per NCDCR Libya requirements.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for submission to NCDCR Libya.
• Inclusion of formulation, manufacturing, QC, and stability data.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols, investigator brochures, and final reports.
• Toxicology studies according to OECD and WHO guidelines for NCDCR Libya submission.
🌏 Why Choose Us for the Libya Market
• Experienced Regulatory Experts – Skilled in NCDCR Libya, WHO, and ICH regulatory frameworks.
• End-to-End Support – From dossier preparation to post-approval compliance.
• Regional Expertise – Proven success across North Africa.
• Efficient Documentation – Streamlined processes for faster regulatory approvals.
• Custom Strategies – Tailored per product type, regulatory pathway, and market requirements.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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