🇮🇳 Regulatory Affairs Services – India
REGULATORY NEXUS GLOBAL
India 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 comprehensive regulatory affairs services and product registration support in India.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Indian regulatory framework and achieving successful product approvals and compliance.
Our regulatory experts provide end-to-end regulatory documentation, dossier preparation and submission support in accordance with Indian regulatory authority requirements.
Regulatory Authorities in India
Pharmaceuticals, cosmetics and medical products in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
CDSCO is responsible for:
• Approval of new drugs and clinical trials
• Regulation of pharmaceuticals and cosmetics
• Import registration of drugs and medical products
• Drug quality monitoring and pharmacovigilance
• Licensing and regulatory compliance
The office of the Drugs Controller General of India (DCGI) oversees national drug approval and regulatory policies.
For traditional medicines such as Ayurveda, Siddha, Unani and herbal products, regulation is handled by the Ministry of AYUSH.
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with Indian regulatory requirements.
Our Mission
To simplify India regulatory compliance and enable companies to successfully register and market their products in India through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for India
Pharmaceutical Regulatory Dossier Preparation
We prepare India-compliant pharmaceutical regulatory dossiers for submission to CDSCO and related authorities.
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 CDSCO guidelines and international regulatory standards.
CTD Format Dossier Preparation
India accepts regulatory submissions based on the **Common Technical Document (CTD) structure.
Our CTD dossier preparation services include:
• Module 1 – Regional Administrative Information
• 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 team ensures documentation complies with ICH guidelines, WHO standards and CDSCO regulatory expectations.
Regulatory Services for Multiple Product Categories in India
Pharmaceuticals
• Generic drug regulatory dossiers
• New drug application documentation
• API documentation and support
• CMC documentation
• Bioequivalence documentation
• Stability study documentation
Nutraceuticals & Food Supplements
Nutraceuticals and food supplements in India are regulated by the Food Safety and Standards Authority of India (FSSAI).
Our services include:
• Product technical documentation
• Ingredient regulatory compliance verification
• Nutraceutical regulatory documentation
• Label compliance documentation
Herbal & Ayurvedic Products
Herbal and Ayurvedic products fall under the regulatory framework of Ministry of AYUSH.
REGULATORY NEXUS GLOBAL provides:
• Ayurvedic and herbal product regulatory dossiers
• Traditional medicine documentation
• Ingredient safety documentation
• Export regulatory documentation
Cosmetics & Personal Care Products
Cosmetic products are regulated under the Drugs and Cosmetics Act 1940.
Our regulatory services include:
• Cosmetic product documentation
• Ingredient regulatory compliance
• Cosmetic import registration dossiers
• 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 Indian products
India Market Entry Support
Our regulatory experts assist companies seeking to enter the Indian healthcare and pharmaceutical market through:
• Regulatory documentation preparation
• CTD-compliant dossier development
• CDSCO regulatory submission support
• Import registration documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in India CDSCO 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.