Regulatory And Research Services for North-America
🌎 Regulatory and Research Services for North America – 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 North American markets. Our services ensure full compliance with FDA, Health Canada, COFEPRIS, and WHO/ICH guidelines, meeting both regional and international standards.
📘 Regulatory Services for North America
Regulatory & Product Registration Support – North America
We assist pharmaceutical, nutraceutical, and cosmetic companies at every stage of regulatory submission and product approval across North America, ensuring smooth market entry and full compliance with local regulatory authorities.
📘 Product Registration Services
• Preparation and submission of 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 North American registration.
• Support in API regulatory documentation, including quality, safety, and stability data.
⚗️ Bioequivalence (BE) Study Support
• Design and coordination of BE studies in FDA/Health Canada-approved CROs.
• Preparation of complete BE study reports in accordance with WHO and regional 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 entry into North American markets.
• Assistance with import/export permissions, inspections, and post-approval compliance.
• Regular updates on FDA, Health Canada, COFEPRIS, and WHO regulatory changes to ensure continuous product compliance.
🧪 Research & Development (R&D) Services – North America
Our R&D services support your product development, validation, and quality assurance activities in compliance with regional 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 regional regulatory requirements.
🧍⚕️ Clinical Trial & Toxicology Support
• Preparation of clinical trial protocols and final study reports.
• Toxicological evaluation in compliance with OECD, WHO, FDA, and Health Canada guidelines.
🌎 Why Choose Us for the North American Market
• Experienced Team – Experts in FDA, Health Canada, COFEPRIS, WHO, and ICH frameworks.
• End-to-End Support – From formulation development to market registration and post-approval compliance.
• Global Exposure – Proven experience across North America, South America, Europe, and Asia.
• Timely Submissions – Streamlined processes ensuring faster approvals.
• Custom Solutions – Tailored strategies for your product type, market, and regulatory pathway.
📘 Regulatory & Dossier Documentation
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⚗️ Bioequivalence & Analytical Studies
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🧪 Technology Transfer & Safety
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🌐 Top Pharma & Regulatory Hashtags – North America
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