Regulatory And Research Services for Spain
🇪🇸 Regulatory and Research Services for Spain – Dossier-DMF Services @ Zoesoe Exports Pvt Ltd
We, Zoesoe Exports Pvt Ltd, specialize in providing end-to-end regulatory and research solutions to pharmaceutical, nutraceutical, herbal, and cosmetic companies aiming to enter the Spanish market.
Our services ensure full compliance with the Spanish Agency of Medicines and Medical Devices (AEMPS) regulations, national standards, and international ICH/WHO guidelines.
📘 Regulatory Services for Spain
Regulatory & Product Registration Support – Spain
We assist pharmaceutical, nutraceutical, and cosmetic companies at every stage of regulatory submission and product approval in Spain, ensuring a smooth market entry and full compliance with AEMPS guidelines.
📘 Product Registration Services
• Preparation and submission of export registration dossiers for prescription (Rx) and OTC products.
• Registration support for Herbal, Ayurveda, Nutraceutical, Veterinary, and Cosmetic products.
• Guidance on local labeling, packaging requirements, and product information leaflets.
📗 Drug Master File (DMF) Services
• Compilation of CTD/ACTD-compliant DMFs for APIs intended for Spain registration.
• Support in API regulatory documentation, including quality, safety, and stability data.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in AEMPS-approved CROs.
• Preparation of complete BE study reports in accordance with WHO and Spain regulatory requirements.
🔬 Analytical Method Validation (AMV) Services
• Validation of analytical methods as per ICH Q2(R2) guidelines.
• Preparation of AMV documentation for regulatory submission and routine QC support.
🧾 Regulatory Consultancy & Compliance
• Comprehensive regulatory guidance for export or local market entry in Spain.
• Assistance with import/export permissions, AEMPS inspections, and post-approval compliance.
• Regular updates on AEMPS and WHO regulatory changes to ensure continuous product compliance.
🧪 Research & Development (R&D) Services – Spain
Our R&D services support your product development, validation, and quality assurance activities in compliance with Spain’s AEMPS and international standards.
💊 Formulation Development
• Development of tablets, capsules, syrups, powders, and injectables.
• Optimization for stability, bioavailability, and efficacy suited to regional conditions.
🧫 Analytical R&D Services
• Assay, dissolution, impurity profiling, and stability testing.
• Quality control method development and routine analytical testing.
📑 Product Development Reports (PDRs)
• Preparation of comprehensive PDRs for regulatory submission.
• Inclusion of manufacturing process, QC methods, and stability data in line with AEMPS requirements.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols and final study reports.
• Toxicological evaluation in compliance with OECD and AEMPS guidelines.
🌏 Why Choose Us for the Spanish Market
• Experienced Team – Experts in AEMPS, WHO, and ICH regulatory frameworks.
• End-to-End Support – From formulation development to market registration and post-approval compliance.
• Global Exposure – Proven experience across ROW, ASEAN, US, and EU markets.
• Timely Submissions – Streamlined processes ensuring faster approvals.
• Custom Solutions – Tailored strategies for your product type, market, and regulatory pathway.
📘 Regulatory & Dossier Documentation – Spain
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⚗️ Bioequivalence & Analytical Studies – Spain
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🧪 Technology Transfer & Safety – Spain
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