Our clients
Who we help
The same product can involve a brand owner, a contract manufacturer, a local importer and a Marketing Authorization Holder. Their obligations are not identical. We help each party understand where it fits before the registration work begins.
RAQ Consultation starts by understanding your role. Choose the description closest to your business.
Why your role matters
Four questions that shape the regulatory plan
The answers decide which National Medicines Regulatory Authority (NMRA) route applies and which documents each party must provide.
- Who owns the brand?The commercial brand owner may be different from the company that legally manufactures the product.
- Who manufactures the product?We identify the legal manufacturer and physical manufacturing site, including any contracted facility.
- Who is responsible locally?The applicant, MAH, importer or authorised agent must be identified according to the applicable NMRA requirements. See MAH and local regulatory support.
- Who will import and sell it?Importation, distribution and post-market responsibilities should be considered alongside registration.
The roles in plain terms
- Brand owner
- The business whose name or trade mark appears on the product. It may or may not make the product itself.
- Legal manufacturer
- The company that takes responsibility for the product's design, quality and compliance as its manufacturer, even if production is contracted out.
- Manufacturing site
- The physical factory where the product is made. One legal manufacturer can use several sites, in Sri Lanka or overseas.
- Importer or distributor
- The Sri Lankan business that brings the product into the country or sells it on.
- Local applicant or MAH
- The party in Sri Lanka that applies to the NMRA and holds the registration. Its exact name, conditions and obligations depend on the product category.
- Regulatory consultant
- An adviser such as RAQ that assesses requirements and prepares and coordinates documentation. A consultant does not take on the applicant's or manufacturer's legal responsibilities.
These are general descriptions to help you identify your role. The NMRA's own terms and requirements differ between medical devices, cosmetics and borderline products, and the service pages explain them for each category.
01 · International manufacturers
Manufacturers looking towards Sri Lanka
Documents prepared for one market cannot always be submitted unchanged in another. We help overseas manufacturers understand the Sri Lankan route, review their existing certificates and technical files, and work with their appointed local party on the information NMRA expects.
What usually matters
- Which party in Sri Lanka will apply for registration and hold it.
- Whether the manufacturing site needs NMRA approval or certification evidence before the products can be registered.
- Which existing approvals, certificates and technical documents can be used, and which documents need updating, legalising or translating.
Next step: Share your product list, intended use, legal manufacturer, manufacturing site and existing certifications or approvals. Do not send confidential dossiers in the first message.
02 · Sri Lankan importers and distributors
Importers and distributors building a compliant product range
Before placing an order, it is worth knowing whether the product can be registered, which authorisations the overseas supplier can provide, and who will hold the local responsibilities. We review those questions with importers and help plan the documentary work.
What usually matters
- Whether your business is the applicant, and what authorisation it needs from the manufacturer or brand owner.
- Which documents only the overseas supplier can provide, and how long they take to obtain.
- Whether sample import licences or other licences are needed before registration.
Next step: Tell us the brand, product category, country of origin, manufacturer and any documents already received.
03 · Private-label and own-brand businesses
Brand owners working with contract manufacturers
You may control the brand without being the legal manufacturer. That distinction matters, whether the product is made in Sri Lanka or overseas. We review the manufacturing arrangement, responsibilities, label, claims and product information before identifying the regulatory work required.
What usually matters
- Who is the legal manufacturer, and whether that is your business or the contract manufacturer.
- Whether the product is made locally or imported, because the NMRA routes differ.
- Which formulation, testing and site documents the contract manufacturer will release to you or to the NMRA.
Next step: Tell us who develops the formulation, who manufactures and releases the product, whose name appears on the label and where you intend to sell it.
04 · Local manufacturers
Sri Lankan manufacturers preparing to produce or expand
Regulatory readiness begins at the facility, not at the product-registration counter. We help local manufacturers examine their site documentation, quality system, processes and product plans, then organise the work in the order required for the relevant category.
What usually matters
- The manufacturing-site route for your product category, which comes before product registration: NMRA site approval and GMP evidence for medical devices and borderline products, or NMRA acknowledgement and ISO 22716:2007 certification for cosmetics.
- Whether your quality system and documentation are ready for an NMRA GMP inspection or an independent certification audit, which are different things.
- The order of applications for each product, and the evidence each one needs.
Next step: Describe your facility, product categories, present quality-system status and whether you already hold any relevant approvals or certificates.
05 · International regulatory consultancy partners
Regulatory partners supporting clients in Sri Lanka
International consultants, compliance firms and testing organisations may need a Sri Lankan regulatory counterpart. RAQ can support local requirement assessments, document-gap reviews, applicant coordination and communication with the relevant parties under an agreed scope.
Common difficulties
- Limited first-hand knowledge of current NMRA procedures, forms and submission practice.
- Coordinating documents, questions and timelines between a client, a manufacturer and the local applicant.
Next step: Explain the product category, your client's regulatory status, the intended role of the local applicant and the work you would like RAQ to undertake.
Tell us how your business is involved
Some companies perform more than one role. A local importer may also own a brand, while a manufacturer may use several physical sites. We can begin by clarifying those relationships before discussing the regulatory pathway.
RAQ provides independent advice and coordination support. NMRA and other competent bodies make regulatory decisions and issue approvals.
Contact RAQ
Discuss your project
Tell us your role, the products involved and where they are made. We will reply with a suitable next step.
Please do not send formulations, confidential dossiers or other proprietary information in a first message.