🇹🇩 Regulatory Affairs Services – Chad

REGULATORY NEXUS GLOBAL

Chad 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, providing professional regulatory affairs services and product registration support for Chad.

We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Chad regulatory framework and successfully registering their products for the Chadian market.

Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Chad regulatory authority requirements.

Chad Regulatory Authority

Pharmaceutical products and healthcare products in Chad are regulated by the Ministry of Public Health Chad through the Directorate of Pharmacy and Medicines Chad.

The authority is responsible for:

• Pharmaceutical product registration and marketing authorization
• Regulation of medicines and biological products
• Licensing of pharmaceutical importers and distributors
• Monitoring drug quality and safety
• Pharmacovigilance and post-marketing surveillance

REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with Chad regulatory requirements.

Our Mission

To simplify Chad regulatory compliance and enable companies to successfully register and market their products in Chad through scientifically sound and compliant regulatory documentation.

Our Core Regulatory Services for Chad

Pharmaceutical Product Registration

We prepare Chad-compliant pharmaceutical regulatory dossiers for submission to the Ministry of Public Health.

Our services include preparation of:

• Administrative documentation
• Product formulation and composition details
• Manufacturing process documentation
• Quality control specifications and analytical methods
• Stability study reports
• Certificate of Pharmaceutical Product (CPP) documentation
• GMP documentation
• Bioequivalence documentation (where required)

All dossiers are prepared according to Chadian regulatory guidelines and international regulatory standards.

CTD Dossier Preparation

Pharmaceutical product registration in Chad generally follows documentation structured according to the **Common Technical Document (CTD) format.

Our CTD dossier preparation services include:

Module 1 – Administrative Information (Chad-specific requirements)
Module 2 – Quality Overall Summary (QOS)
Module 3 – Quality / CMC Documentation
Module 4 – Non-Clinical Study Reports
Module 5 – Clinical / Bioequivalence Study Reports

Our regulatory experts ensure dossiers comply with ICH guidelines, WHO standards and Chadian regulatory expectations.

Pharmaceutical Registration Process in Chad

The general process for pharmaceutical product registration in Chad includes:

  1. Appointment of a local Chadian importer or authorized distributor.

  2. Submission of CTD regulatory dossier and legal documentation to the Ministry of Public Health.

  3. Technical evaluation of product quality, safety and efficacy.

  4. Regulatory review and compliance assessment.

  5. Approval and issuance of marketing authorization for Chad.

The registration process typically takes 10–14 months depending on product category and regulatory review timeline.

Regulatory Services for Multiple Product Categories in Chad

Pharmaceuticals

• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation

Nutraceuticals & Health Supplements

Chad has an emerging market for nutraceuticals and dietary supplements.

Our services include:

• Product technical documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation

Herbal & Traditional Products

Traditional herbal medicines are widely used across Central Africa.

We provide regulatory documentation support including:

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

Cosmetics & Personal Care Products

Cosmetic products must comply with national safety and regulatory documentation requirements before being marketed in Chad.

Our services include:

• Cosmetic Product Information File (PIF) preparation
• Ingredient regulatory compliance verification
• Cosmetic product registration documentation
• Product safety documentation

Veterinary Products

• Veterinary drug regulatory dossiers
• Product technical documentation
• Export regulatory documentation

Additional Regulatory Support

REGULATORY NEXUS GLOBAL also provides:

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

Chad Market Entry Support

Our regulatory experts assist companies seeking to enter the Chadian pharmaceutical and healthcare market through:

• Regulatory documentation preparation
• CTD-compliant dossier development
• Ministry of Public Health regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting

Why Choose REGULATORY NEXUS GLOBAL

✔ Experienced regulatory affairs professionals
✔ Expertise in Central African regulatory requirements
✔ ICH-compliant regulatory documentation
✔ Support from product development to registration
✔ Reliable scientific documentation
✔ End-to-end regulatory solutions

About REGULATORY NEXUS GLOBAL

REGULATORY NEXUS GLOBAL operates as the scientific regulatory arm of Zoesoe Exports Pvt Ltd, providing global regulatory consultancy, export support and regulatory documentation services for pharmaceutical, herbal, nutraceutical and cosmetic products across international markets.