Regulatory And Research Services for Regulatory-Services-Coverage-by-Domestic-Market

Regulatory Services Coverage by Domestic Market

@ Zoesoe Exports Pvt Ltd – Dossier & DMF Solutions

We provide end-to-end regulatory, research, and compliance solutions for pharmaceutical, nutraceutical, herbal, and cosmetic companies, tailored to domestic markets around the world. Our services ensure full compliance with local regulatory authorities, national standards, and international ICH/WHO guidelines.

1. Asia

Regulatory Authorities: CDSCO (India), MFDS (South Korea), TFDA (Taiwan), NMPA (China), etc.
Services:

• Product registration for Rx, OTC, herbal, nutraceutical, cosmetic, and veterinary products

• Drug Master File (DMF) compilation & submission

• Bioequivalence (BE) study coordination and report preparation

• Analytical Method Validation (AMV) and R&D support

• Clinical trial & toxicology protocols

2. Africa

Regulatory Authorities: SAHPRA (South Africa), NAFDAC (Nigeria), TFDA (Tanzania), Ministry of Health in other countries
Services:

• Export registration dossiers & local approvals

• DMF and API regulatory documentation support

• BE studies and analytical method validation

• Local labeling and post-approval compliance

3. CIS Countries

Regulatory Authorities: EAEU, national authorities in Russia, Kazakhstan, Belarus, Armenia, etc.
Services:

• Full regulatory submission & product registration across CIS markets

• CTD/ACTD DMF preparation

• Bioequivalence studies according to regional and WHO standards

• Technology transfer, QC, and method validation

4. South-West Europe

Regulatory Authorities: EMA, national authorities (Germany, France, Spain, Italy, Portugal, etc.)
Services:

• Market authorization, Rx/OTC/herbal/cosmetic registration

• DMF compilation for APIs

• Bioequivalence & analytical studies in EMA-approved CROs

• Clinical trial & toxicology support per EU guidelines

5. Central America & Caribbean

Regulatory Authorities: COFEPRIS (Mexico), DIGEMED (Peru), INVIMA (Colombia), PAHO-recognized authorities
Services:

• Export registration dossiers & local product approvals

• CTD/ACTD DMF preparation

• Bioequivalence & analytical support

• Post-approval compliance and import/export assistance

6. South America

Regulatory Authorities: ANVISA (Brazil), INVIMA (Colombia), DIGEMID (Peru), other national agencies
Services:

• Product registration for Rx/OTC/herbal/nutraceutical/cosmetic products

• DMF preparation and submission

• Bioequivalence study coordination

• Technology transfer and regulatory consultancy

7. North America

Regulatory Authorities: FDA (USA), Health Canada, COFEPRIS (Mexico)
Services:

• Product registration & dossier submission

• DMF for APIs

• BE study support in FDA/Health Canada-approved CROs

• Clinical trials, toxicology evaluation, and compliance assistance

Key Highlights Across All Domestic Markets

• End-to-End Support: Formulation → R&D → Registration → Post-Approval Compliance

• Global Expertise: Proven experience across multiple regions

• Timely Submission: Optimized processes for faster regulatory approvals

• Custom Solutions: Tailored strategies for product type, market, and regulatory pathway

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