Greetings from Freyr Sri Lanka
Freyr is one of the largest global, Regulatory-focused solutions and services companies. We support Life Sciences companies entering Sir Lankan pharma market in their entire Regulatory value chain, ranging from Regulatory strategy, market intelligence, local representation, and post-approval product maintenance functions.
We support you with registering your drugs, medical devices, food supplements, and cosmetic products with the National Medicines Regulatory Authority (NMRA), the key Regulatory authority of Sri Lanka. Our on-ground team of Sri Lankan experts ensures a smooth market entry of your products.
Industries We Serve
NMRA is the key drug Regulatory Agency in Sri Lanka. The NMRA ACT, No. 5 of 2015 provides the authority to the NMRA to regulate and control the manufacturing, importation, storage, distribution, transportation, pricing, wholesale and retail sale, advertising and disposal of medicines.
- End-to-end registration support
- Authorized Local agent support
- Manufacturing site approval support
- Sample import license support
- Compilation and Submission of the dossier to the NMRA
- Query support management till approval
NMRA, under the Ministry of Health (MoH) is responsible for regulation and control of registration, Licencing, manufacturing, importation, and other aspects pertaining to medical devices in Sri Lanka.
- End-to-end Medical Device Registration
- Medical Device Compliance in Sri Lanka
- Authorized Local Agent
- Manufacturing Site Registration
- Application submission to the NMRA
- Query support management till approval
- Translation Services
Food supplements/dietary supplements fall under the borderline category, as they have combined characteristics of foods along with medicine. According to the National Medicines Regulatory Authority (NMRA) Act No. 05 of 2015, the NMRA Sri Lanka is responsible for the regulation and control of registration, licensing, manufacture, importation, and all other Regulatory aspects pertaining to borderline products.
- Preliminary Evaluation (Product Classification)
- Formula Review/Ingredients Assessment
- Food Label Review and Claims Review
- NMRA Product Registration
- Interaction with the FCA and NMRA Sri Lanka
- Legal Representation Services
- Regulatory Support Report
The cosmetic products industry in Sri Lanka has recorded a gradual growth in the past few years, with an eventual increase in the supply of these products in the market. With the rise in per capita income, urbanization, and use of internet, consumers have become much more informed about their skin types, and thus, are moving towards international trends, which has resulted in an increased demand of locally made private label cosmetics and imported cosmetics in Sri Lanka.
- Cosmetics Classification as per the NMRA Cosmetics Guidelines
- Cosmetic Formulation Review/ Cosmetics Ingredient Review
- Cosmetic Registrations application with the National Medicines Regulatory Authority (NMRA)
- Provisional Registration
- Full Registration
- Cosmetics Legal Representation and Importation Services
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An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Support, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.Know More
Our Regional Expertise
We are a global firm and we have local expertise across the following countries.