REGULATORY NEXUS GLOBAL – Global Regulatory Affairs Services

REGULATORY NEXUS GLOBAL

Global Regulatory Affairs Solutions for Pharmaceutical, Nutraceutical, Herbal and Cosmetic Products

REGULATORY NEXUS GLOBAL is a specialized scientific and regulatory division of Zoesoe Exports Pvt Ltd, India, dedicated to providing comprehensive global regulatory affairs services for regulated international markets.

We support pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating complex international regulatory requirements and achieving successful product registrations worldwide.

Our team of experienced regulatory professionals provides end-to-end regulatory documentation, dossier preparation and submission support for multiple global regulatory jurisdictions.

Our Mission

To simplify global regulatory compliance and enable companies to successfully register and market their products across international markets through scientifically sound and compliant regulatory documentation.

Our Core Regulatory Services

CTD Dossier Preparation

We prepare Common Technical Document (CTD) dossiers according to ICH guidelines for pharmaceutical product registration in regulated markets.

Our CTD services include:

• Module 1 – Regional Administrative Information
• Module 2 – Quality Overall Summary (QOS) and Expert Summaries
• Module 3 – Quality / CMC Documentation
• Module 4 – Non-Clinical Study Reports (where applicable)
• Module 5 – Clinical Study Reports / Bioequivalence Reports

We ensure that all documents comply with ICH, WHO, USFDA, EMA and other regulatory authority requirements.

ACTD Dossier Preparation

We prepare ASEAN Common Technical Dossier (ACTD) for product registration in ASEAN countries including:

• Thailand
• Vietnam
• Malaysia
• Philippines
• Indonesia
• Cambodia
• Laos
• Myanmar

Our ACTD dossiers include complete Part I, II, III and IV documentation with country-specific compliance.

Country-Specific Regulatory Dossiers

REGULATORY NEXUS GLOBAL also provides country-specific regulatory documentation and submission support for markets including:

• Africa (ROW Markets)
• Middle East
• Latin America
• CIS Countries
• Asia & ASEAN Markets
• Europe (EU-CTD compliance)

We customize regulatory dossiers based on local authority requirements and submission formats.

Regulatory Services for Multiple Product Categories

We provide regulatory documentation services for:

Pharmaceuticals

• Generic drug dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation

Nutraceuticals & Food Supplements

• Export registration dossiers
• Technical documentation
• Ingredient compliance documentation

Herbal & Ayurvedic Products

• Traditional medicine dossiers
• Herbal product regulatory documentation
• Export registration support

Cosmetics & Cosmeceuticals

• Cosmetic product information file (PIF)
• Cosmetic export registration dossiers
• Ingredient regulatory compliance

Veterinary Products

• Veterinary drug registration dossiers
• Export regulatory documentation

Additional Regulatory Support

We also provide:

• Technical document writing
• Product development reports
• Analytical method validation documentation (ICH Guidelines)
• Clinical trial and bioequivalence report documentation
• Regulatory gap analysis
• Regulatory strategy planning
• Export registration support

Global Market Support

REGULATORY NEXUS GLOBAL supports product registration and regulatory compliance in:

• Africa
• Middle East
• ASEAN
• Europe
• Latin America
• CIS Countries
• South Asia

Our regulatory team ensures that dossiers meet the latest international regulatory standards and country-specific submission requirements.

Why Choose REGULATORY NEXUS GLOBAL

✔ Experienced regulatory affairs professionals
✔ ICH-compliant dossier preparation
✔ Expertise in multiple global markets
✔ Support from product development to registration
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions

About Zoesoe Exports Pvt Ltd

REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, India, a company engaged in global export support, regulatory consultancy, and contract manufacturing coordination for pharmaceutical, herbal, nutraceutical and cosmetic products.

“Navigating Global Regulations with Scientific Precision”

Excellence in global export support.

📌 Frequently Asked Questions (FAQ) – REGULATORY NEXUS GLOBAL

1. What is REGULATORY NEXUS GLOBAL?

REGULATORY NEXUS GLOBAL is a specialized scientific regulatory division of Zoesoe Exports Pvt Ltd, India, providing end-to-end global regulatory affairs services for pharmaceutical, nutraceutical, herbal, veterinary, and cosmetic products. We support companies in preparing regulatory dossiers and achieving product registration in international markets.

2. What regulatory services do you provide?

We provide a complete range of regulatory affairs services including:

• CTD Dossier Preparation (ICH format)
• ACTD Dossier Preparation (ASEAN format)
• Country-Specific Regulatory Dossiers
• Technical Document Writing
• Product Development Reports
• Analytical Method Validation Documentation
• Bioequivalence Study Documentation
• Regulatory Gap Analysis
• Export Registration Support

3. What is a CTD dossier?

The Common Technical Document (CTD) is the internationally accepted format used for pharmaceutical product registration in many regulated markets.

The CTD format includes:

• Module 1 – Administrative information
• Module 2 – Quality Overall Summary and expert reports
• Module 3 – Quality / CMC documentation
• Module 4 – Non-clinical study reports
• Module 5 – Clinical study reports

REGULATORY NEXUS GLOBAL prepares complete CTD dossiers compliant with ICH guidelines.

4. What is ACTD?

ACTD (ASEAN Common Technical Dossier) is the regulatory format used in ASEAN countries for product registration.

It includes:

• Part I – Administrative data
• Part II – Quality documentation
• Part III – Non-clinical data
• Part IV – Clinical data

We prepare ACTD dossiers for ASEAN regulatory submissions.

5. Which countries or regions do you support?

REGULATORY NEXUS GLOBAL supports regulatory documentation and registration for multiple international markets including:

• Africa (ROW markets)
• Middle East
• ASEAN Countries
• Europe
• Latin America
• CIS Countries
• South Asia

6. What types of products do you support for regulatory registration?

We provide regulatory support for:

• Pharmaceutical products (finished formulations and APIs)
• Nutraceuticals and food supplements
• Herbal and Ayurvedic products
• Cosmetics and cosmeceuticals
• Veterinary medicines

7. Do you provide ready CTD dossiers for licensing or technology transfer?

Yes. In certain cases, we can provide ready EU-CTD compliant dossiers for selected pharmaceutical products, including detailed Module 3 (Quality / CMC) documentation suitable for regulatory submission or licensing discussions.

8. Can you support regulatory submissions in African and Middle East markets?

Yes. We have extensive experience in preparing country-specific regulatory dossiers for Africa and Middle East markets, including documentation required by national regulatory authorities.

9. Do you provide regulatory strategy support before product registration?

Yes. We help companies with:

• Regulatory strategy planning
• Product documentation review
• Gap analysis of available technical documents
• Identification of additional studies or data requirements

This ensures smoother and faster regulatory approvals.

10. Do you assist with export registration for herbal and nutraceutical products?

Yes. REGULATORY NEXUS GLOBAL provides complete export registration support for herbal and nutraceutical products including preparation of technical dossiers and regulatory documentation required for international markets.

11. How long does it take to prepare a regulatory dossier?

The preparation time depends on the product and availability of technical data. Typically:

• CTD dossier preparation: 4–8 weeks
• ACTD dossier preparation: 3–6 weeks
• Country-specific export registration dossiers: 2–5 weeks

12. How can we start working with REGULATORY NEXUS GLOBAL?

To begin collaboration, simply contact our regulatory team with:

• Product name
• Dosage form / composition
• Target country or market
• Available technical documents

Our experts will evaluate the documentation and provide a regulatory strategy and proposal.