Regulatory and Research Services for India – Dossier-DMF Services

Regulatory and Research Services for India – 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 Indian market. Our services are designed to ensure full compliance with CDSCO regulations, Ministry of AYUSH guidelines, FSSAI requirements, and international standards.

Regulatory Services for India

Regulatory Support – India

We provide regulatory assistance to pharmaceutical, nutraceutical, herbal, AYUSH, and cosmetic companies in India, as per CDSCO, AYUSH, and FSSAI guidelines.

Regulatory Affair Services

• Readymade Dossier template for submission purpose

• Preparation of registration dossiers for prescription (Rx) and OTC products.

• Document support for Herbal, Ayurveda, Siddha, Unani, Nutraceutical, Veterinary, and Cosmetic products.

Drug Master File (DMF) Services

• Readymade DMF template for submission purpose

• Compilation of CTD/ACTD-compliant DMFs for APIs intended for India registration.

• Support in API regulatory documentation covering quality, safety, and stability data.

Bioequivalence (BE) Study Support

• Readymade BE template for submission purpose

• Design and coordination of BE studies in CDSCO-approved CROs.

• Full BE report preparation in accordance with CDSCO, ICH, and WHO regulatory guidelines.

Analytical Method Validation (AMV) Services

• Readymade AMV template for submission purpose

• Validation of analytical methods as per ICH Q2(R2) guidelines.

• Preparation of AMV documentation for regulatory submission and routine QC support.

Regulatory Consultancy & Compliance

• End-to-end regulatory guidance for export or local market entry in India.

• Assistance with import/export permissions, CDSCO inspections, GMP compliance, and post-approval requirements.

• Continuous updates on CDSCO, AYUSH, FSSAI, WHO, and ICH regulatory changes to ensure ongoing product compliance.

Research & Development (R&D) Services – India

Our R&D services support your product development, validation, and quality assurance requirements to meet Indian regulatory standards.

Formulation Development

• Development of tablets, capsules, syrups, powders, injectables, and topical formulations.

• Optimization for stability, bioavailability, and efficacy as per Indian climatic zone requirements.

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 CDSCO requirements.

Clinical Trial & Toxicology Support

• Preparation of clinical trial protocols and final study reports.

• Toxicological evaluation following OECD, CDSCO, and AYUSH guidelines.

Why Choose Us for the India Market

• Experienced Team – Experts in CDSCO, AYUSH, FSSAI, WHO, and ICH regulatory frameworks.

• End-to-End Support – From formulation development to market registration and compliance.

• Global Exposure – Proven expertise in ROW, ASEAN, US, EU, GCC, and Indian regulatory environments.

• Timely Submissions – Streamlined processes for faster approvals.

• Custom Solutions – Tailored strategies for your product type, market segment, 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 – India

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