Strategic Regulatory Partner for Success in Sri Lanka

Greetings from

Pharma Wizard Sri Lanka

Pharma Wizard is a global regulatory leader, delivering comprehensive services and solutions to life sciences companies across the entire regulatory value chain. With a presence in over 120 countries, we support organizations in their “local to global” expansion journey.
At Pharma Wizard Sri Lanka, we assist companies in registering their products with the National Medicines Regulatory Authority (NMRA). Our services include regulatory strategy, market intelligence, in-country representation, post-marketing surveillance (PMS) functions, and more. We also offer next-generation regulatory software solutions that streamline the entire NMRA registration lifecycle for improved efficiency and compliance

Industries We Serve in Sri Lanka

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

FBR

Company Profile

Portfolio

Presentation

Order

Food & Food Supplements Product Services

Categories Supported

Sustainability Services