🇱🇰 Regulatory Affairs Services – Sri Lanka
REGULATORY NEXUS GLOBAL
Sri Lanka 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 Sri Lanka.
We assist pharmaceutical, nutraceutical, herbal, veterinary and cosmetic companies in navigating the Sri Lankan regulatory framework and successfully registering their products for the Sri Lankan market.
Our regulatory specialists provide complete regulatory documentation, dossier preparation and submission support aligned with Sri Lankan regulatory authority requirements.
Sri Lanka Regulatory Authority
Pharmaceutical products, medical devices and cosmetics in Sri Lanka are regulated by the National Medicines Regulatory Authority (NMRA) under the Ministry of Health Sri Lanka.
The authority is responsible for:
• Pharmaceutical product registration and marketing authorization
• Regulation of medicines, biological products and medical devices
• Regulation of cosmetics and healthcare products
• Licensing of pharmaceutical importers and distributors
• Monitoring drug quality, safety and pharmacovigilance
REGULATORY NEXUS GLOBAL provides regulatory documentation and compliance support aligned with NMRA regulatory requirements.
Our Mission
To simplify Sri Lanka regulatory compliance and enable companies to successfully register and market their products in Sri Lanka through scientifically sound and compliant regulatory documentation.
Our Core Regulatory Services for Sri Lanka
Pharmaceutical Product Registration
We prepare Sri Lanka–compliant pharmaceutical regulatory dossiers for submission to the National Medicines Regulatory Authority.
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 Sri Lanka regulatory guidelines and international regulatory standards.
CTD Dossier Preparation
Sri Lanka accepts pharmaceutical submissions based on the **Common Technical Document (CTD) format.
Our CTD dossier preparation services include:
• Module 1 – Regional Administrative Information (NMRA 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 NMRA regulatory requirements.
Pharmaceutical Registration Process in Sri Lanka
The general process for pharmaceutical product registration in Sri Lanka includes:
Appointment of a local Sri Lankan agent or importer.
Submission of CTD regulatory dossier and legal documentation to NMRA.
Technical evaluation of product quality, safety and efficacy.
Regulatory review and laboratory testing where required.
Approval and issuance of marketing authorization in Sri Lanka.
The registration process typically takes 6–12 months depending on the product category and regulatory review.
Regulatory Services for Multiple Product Categories in Sri Lanka
Pharmaceuticals
• Generic drug registration dossiers
• API documentation and DMF support
• Bioequivalence documentation
• CMC documentation
• Stability study documentation
• GMP compliance documentation
Nutraceuticals & Food Supplements
Sri Lanka has a growing market for health supplements and nutraceutical products.
Our services include:
• Food supplement regulatory documentation
• Ingredient regulatory compliance verification
• Label compliance documentation
• Export regulatory documentation
Herbal & Ayurvedic Products
Ayurvedic and herbal medicines are widely used in Sri Lanka.
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 safety and regulatory documentation requirements before marketing in Sri Lanka.
Our services include:
• Cosmetic product technical documentation
• 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 Sri Lanka
Sri Lanka Market Entry Support
Our regulatory experts assist companies seeking to enter the Sri Lankan pharmaceutical and healthcare market through:
• Regulatory documentation preparation
• CTD-compliant dossier development
• NMRA regulatory submission support
• Import/export regulatory documentation
• Market entry regulatory consulting
Why Choose REGULATORY NEXUS GLOBAL
✔ Experienced regulatory affairs professionals
✔ Expertise in Sri Lanka NMRA 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.