Services
Your End-to-End Partner for Regulatory and Quality Excellence
From initial product classification to achieving GMP certification, we provide a comprehensive suite of services to ensure your products meet Sri Lanka’s highest standards for safety and quality.
Our Core Disciplines
Two Pillars of Market Success
Our services are built on two interconnected pillars: Regulatory Affairs to ensure your products are legally compliant and approved for the market, and Quality Assurance to ensure your systems and facilities meet the required standards of excellence.
Regulatory Affairs
Your Path to Market
Authorization
We are experts in navigating the NMRA’s regulatory framework. Our goal is to ensure your products achieve registration efficiently and correctly, minimizing delays and ensuring full compliance.
Product Registration
Marketing Authorization Holder (MAH) Services
Regulatory Strategy & Classification
Quality Assurance
Building a Foundation of Excellence
We help local manufacturers build and maintain world-class quality systems. Our consulting services ensure your facility is not just compliant, but operates at the highest standard of Good Manufacturing Practices (GMP).
GMP Consulting (Medical Devices & Cosmetics)
ISO 9001 Quality Management Systems
Internal Audits & Inspection Readiness
Our Services
A Solution for Every Need
Whether you are a foreign manufacturer seeking market access or a local producer aiming for GMP certification, we have a specialized service to meet your needs.
Regulatory Affairs
Marketing Authorization Holder (MAH)
Your official, in-country legal representative in Sri Lanka. We manage all regulatory responsibilities for foreign manufacturers, from registration to post-market surveillance.
Medical Device Registration
Expert navigation of the NMRA registration process for all classes of medical devices and IVDs, including support for the new Reliance Pathway.
Cosmetics Registration
Comprehensive support to ensure your cosmetic products meet all NMRA requirements, from ingredient review and labeling to dossier submission.
Borderline Products Registration
Specialized guidance for products that fall between categories. We help you achieve correct classification and navigate the two-step registration process.
Quality Assurance
ISO 22716 (Cosmetics GMP)
End-to-end consulting to help local cosmetics manufacturers achieve mandatory ISO 22716 certification and meet the new NMRA requirement.
Medical Device GMP
Prepare your local manufacturing facility for a successful NMRA GMP inspection. We help you implement a robust QMS based on ISO 13485 principles.
ISO 9001 Consulting
Implement a world-class Quality Management System to enhance customer satisfaction, improve efficiency, and build a culture of continual improvement.
Call to Action
Have a Question About Your
Regulatory or Quality Needs?
We’re here to help. Contact us today for a complimentary consultation to discuss your specific challenges and goals.