About RAQ
We are a Sri Lankan consultancy working with the people responsible for bringing medical devices, cosmetics and borderline products to market, and with the manufacturers who need sound quality systems behind them.
Who we are
Before recommending an application route, we want to understand the product: what it does, what it contains or how it works, where it is made and what claims accompany it. These details determine which documents matter and which questions must be answered.
We work with manufacturers, importers, brand owners and regulatory partners on those questions, then agree on a practical scope of review, preparation and follow-up. The responsible applicant retains its statutory duties; RAQ provides the agreed consultancy support.
RAQ Consultation is a trading name of Healin' (Pvt) Ltd, company registration PV 00282060, based in Panadura, Sri Lanka.
Areas of expertise
General medical devices, IVDs, listed devices and related regulatory documentation, subject to the applicable NMRA route.
Medical devices →Imported and locally manufactured cosmetic products, including ingredient, claim, label and dossier review.
Cosmetics →Preliminary category assessment, classification-related documentation and applicable registration support.
Borderline products →Quality manuals, procedures, internal audits, gap assessments and implementation support.
Quality and GMP →Documentation and communication support for overseas manufacturers and their appointed local parties.
MAH and local regulatory support →Our approach
We ask for the facts needed to understand the product and the applicant's role.
We identify the official guidance, the likely pathway and any uncertainty that needs clarification.
We agree what RAQ will do, what the client must supply and which documents need attention.
We help organise submissions and responses within the agreed scope, keeping a record of changes and outstanding matters.
Where appointed, we assist with post-registration documentation, variations and ongoing regulatory questions.
We say clearly what official guidance requires and what depends on a decision by the authority. Timelines and outcomes are set by the NMRA, so we do not promise approval or an approval date.
Working with businesses
We work with manufacturers and businesses inside and outside Sri Lanka. For overseas clients, we pay particular attention to manufacturing documents, local applicant arrangements and the transfer of accurate information between all parties. Who We Help
Professional responsibility
We distinguish official requirements from professional interpretation and avoid unsupported claims.
We request sensitive product and company information through an agreed process appropriate to the engagement.
We explain what is required, what is missing and what action should follow.
Approvals, registrations and certificates are issued by the relevant authorities or certification bodies, not by RAQ.
Leadership
Managing Director & Regulatory Strategist
Samitha oversees RAQ's regulatory and quality-assurance consulting work, from initial client discussions to technical reviews and project supervision. His focus is on clear requirements, thorough documentation and advice that clients can act on.
Discuss Your ProjectContact RAQ
Tell us about the product, your role and where it is made. We will suggest a suitable next step.
Please do not send formulations, confidential dossiers or other proprietary information in a first message.
