Expert guidance for products that fall between regulatory categories
In the vibrant and evolving healthcare market of Sri Lanka, the category of borderline products presents unique regulatory challenges. RAQ by Healin' Pvt Ltd specializes in demystifying this process, ensuring your products align seamlessly with the National Medicines Regulatory Authority (NMRA) standards.
We begin by guiding you through the Preliminary Evaluation for product classification, setting the stage for a successful registration journey.
Whether you're a local manufacturer seeking formulation approval or a foreign manufacturer requiring a sample import license, RAQ is your expert guide.
Our expertise extends to the complete registration process for both local and foreign products, ensuring every step is meticulously managed for NMRA compliance.
At RAQ by Healin' Pvt Ltd, we understand the intricacies of borderline product registration. Our services include:
Detailed guidance on the required documentation for Preliminary Evaluation and Product Registration. We ensure all paperwork is complete and compliant with NMRA requirements.
Assistance in navigating the requirements for formulation approval and import licenses. Our team stays current with all regulatory changes and updates.
Strategic advice on meeting NMRA's rigorous standards, including labeling and language requirements. We ensure your product meets all technical specifications.
Expert management of the entire registration process, ensuring your product complies with Sri Lankan regulations from submission to approval.
Our team's in-depth knowledge of Sri Lanka's regulatory environment guarantees precise and efficient handling of your product registration.
From documentation to liaison with regulatory bodies, we provide end-to-end support throughout the entire process.
Our goal is not just compliance but ensuring your product's successful entry and sustainability in the Sri Lankan market.
Borderline products are those that may fall into multiple regulatory categories - such as between cosmetics and drugs, or between medical devices and consumer products. Proper classification is crucial for successful registration.
We help determine the correct regulatory pathway for your product based on its composition, intended use, and claims.
Comprehensive evaluation of product risks and appropriate regulatory controls required.
Guidance on product claims and marketing to ensure regulatory compliance while maximizing market potential.
With RAQ by Healin' Pvt Ltd, step into the Sri Lankan healthcare market with confidence, knowing your borderline products are managed by experts dedicated to your success.
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