Our services
Regulatory affairs & quality assurance services
Whether you are registering a product, preparing a manufacturing site or trying to understand your role as a local applicant, the first decision is what sort of support you actually need. Our services are organised around that decision.
Principal services
Choose the service that fits your project
For medical-device manufacturers and their appointed Sri Lankan applicants, we work through product categorisation, registration routes, site and technical records, consolidated dossier preparation and questions raised during evaluation.
Common work
- Pathway assessment
- Dossier gap review
- Consolidated application support
- Questions and variations
A cosmetic formula, a label and a factory certificate tell different parts of the same story. We review them together, then prepare the documentation needed for the imported or locally manufactured product route.
Common work
- Imported cosmetics
- Local manufacturing requirements
- Label and claim review
- Product dossier support
When it is not clear which regulatory category a product belongs in, we assess its intended use, composition and claims, identify the unresolved questions and prepare the available evidence for formal classification. The classification decision is made by the NMRA.
Common work
- Preliminary assessment
- Classification documents
- Local formulation documentation
- Imported-product registration support
For manufacturing teams, we examine how work is actually done, compare existing controls with the required standard and help address gaps through SOPs, training, audits and implementation support. Local medical-device and borderline-product sites need NMRA manufacturing-site approval and GMP evidence; local cosmetic sites follow the NMRA acknowledgement and ISO 22716:2007 certification route. An ISO certificate does not replace NMRA site approval.
Common work
- ISO 22716 readiness
- ISO 13485 support
- ISO 9001 systems
- GMP and document control
We work alongside overseas manufacturers and their appointed Sri Lankan applicants to clarify responsibility, gather documents and manage regulatory communication. This is consultancy support; the legal duties of the appointed party remain with that party.
Common work
- Responsibility mapping
- Document coordination
- Local-agent engagement support
- Ongoing regulatory communication
Choosing a service
Not sure which service applies?
Tell us what the product does, where it is made and what you are trying to achieve. We can help establish whether the first task is a category assessment, document review, registration plan or manufacturing-readiness exercise.
| If you… | Start with |
|---|---|
| want to register a medical device or in-vitro diagnostic | Medical device regulatory affairs |
| import or make a cosmetic, such as skin care, hair care or colour cosmetics | Cosmetic regulatory affairs |
| have a product with active ingredients or health-related claims that is not clearly a medicine, cosmetic, food or device | Borderline product regulatory affairs |
| manufacture in Sri Lanka and need to prepare your site or quality system | Quality assurance and GMP consulting |
| are an overseas manufacturer working with, or looking for, a local agent (MAH) in Sri Lanka | MAH and local regulatory support |
| are not sure which category your product belongs to | Borderline product regulatory affairs, or contact us with a short description |
| are a regulatory consultancy with a client entering Sri Lanka | Who We Help: regulatory partners |
Across all areas
The work behind a complete application
Regulatory projects rarely depend on one document. Names, models, manufacturing addresses, claims and technical evidence must agree across the file. We help the responsible parties find gaps, resolve inconsistencies and keep a reliable record of what has been submitted and what remains open.
- Document gap review
Identify missing, incomplete, expired or inconsistent documents against the applicable requirements. - Labels and claims
Review information presented to consumers or healthcare professionals against the relevant product category and supporting evidence. - Regulatory correspondence
Help the responsible applicant prepare clear responses to regulatory observations and document requests. - Post-registration matters
Assist with applicable renewals, amendments, regulatory changes and document updates.
Who we work with
Local requirements, international documentation
We work with Sri Lankan businesses and overseas manufacturers preparing to supply the Sri Lankan market. We clarify who will provide each document, who is authorised to submit it and what must be completed before the next stage.
Who We Help explains how we work with each type of client.
Contact RAQ
Discuss a regulatory project
Tell us about the product, your role and where it is made. We will suggest which service applies and a suitable next step.
Please do not send formulations, confidential dossiers or other proprietary information in a first message.