Medical & Products Registration

Expert Regulatory Guidance from Classification

to Compliance

We are your strategic partner for Regulatory Affairs and Quality Assurance in the Medical Device and Cosmetics sectors. We navigate the complexities, so you can focus on growth.

Challenge & Solution

Feeling Lost in Regulation? You're Not Alone

The Challenge

Navigating the NMRA, achieving GMP certification, and ensuring post-market compliance can be a daunting, resource-intensive process. Delays and missteps can cost you time, money, and market opportunity.

The Solution

RAQ provides clarity and direction. We transform regulatory hurdles into a clear, manageable pathway. Our local expertise and end-to-end support ensure your journey to compliance is efficient, predictable, and successful.

Our Services

Your End-to-End Compliance Partner

From initial strategy to final approval, we offer a comprehensive suite of services tailored to your specific needs.

Product Registration

We manage the entire NMRA registration lifecycle for Medical Devices, Cosmetics, and Borderline Products. Our meticulous approach ensures your dossier is accurate, complete, and submitted for timely review.

Marketing Authorization Holder (MAH)

For foreign manufacturers, we act as your official, in-country MAH. We are your legal presence, handling all communication with the NMRA and ensuring your products remain compliant in the Sri Lankan market.

Quality & GMP Consulting

We guide local manufacturers to achieve and maintain critical quality certifications, including ISO 22716 (Cosmetics GMP), NMRA GMP for Medical Devices, and ISO 9001. Elevate your operations to meet global standards.

Professional Staff

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Kind Of Madicine

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Registration Products

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Our Process

Our Proven Path to Success

We’ve simplified the engagement process into three clear steps.

Discovery & Strategy

We start with a thorough consultation to understand your products, goals, and specific challenges. Based on this, we develop a tailored regulatory or quality strategy with clear timelines and deliverables.

Flawless Execution

Our team handles all the heavy lifting: dossier preparation, submissions, communication with authorities, and implementation of quality systems. You receive regular, transparent updates at every stage.

Market Success & Beyond

We don't stop at approval. We provide ongoing support, including post-market surveillance, renewal management, and intelligence on regulatory changes to ensure your long-term success.

Comprehensive Services

Empowering Global Brands and Local Pioneers

For Global Innovators

Bringing Your Products to Sri Lanka?

Let us be your expert on the ground. As your dedicated MAH, we make market entry straightforward and sustainable. Focus on innovation; we'll handle the compliance.

For Local Pioneers

Ready to Compete on a Global Scale?

Quality certification is your passport to new markets and greater trust. Our GMP and ISO consulting services are designed to elevate your manufacturing practices to international standards.

Testimonials

Expertise You Can Trust

"RAQ's guidance was invaluable. They simplified a complex process and their team was professional, responsive, and incredibly knowledgeable. They are the go-to experts for regulatory affairs in Sri Lanka."

Hazel Lily Ceo of the

What We Offer

Have a Project in Mind?

Let’s turn your regulatory challenges into market opportunities. Schedule a free, no-obligation consultation with our experts today.