Tracc
WELCOME TO TRACC GLOBAL
Welcome to Tracc Gloobal, a leading medical device consultancy dedicated to providing exceptional services and expertise to the healthcare industry. With a deep understanding of the complex and evolving landscape of medical device regulations, we are committed to helping our clients navigate the challenges and achieve success in their endavours.
Who are we and what we do
We are your One Point Solution who’ll always provide you with the right TRACC.
Assist with medical device registration, obtaining an import/ manufacturing license, clarification from the central drug standard control organization (CDSCO).
Support for diagnostic kit-related activities, including registration of notified and non-notified kits, obtaining import and test licenses, conducting performance evaluations etc.
TRACC Global specialize in end-to-end certification support, helping clients achieve and maintain compliance across global markets, including ISO, CE, USFDA, and more. With our expert team and deep industry knowledge, we streamline the certification process, ensuring that products meet the highest safety, quality, and performance standards.
Food Safety Standard Authority of India (FSSAI) is an apex national food regulatory body in India hence it is mandatory to comply with FSSA 2206 & FSSR 2011 requirements. One must comply with the Food Safety and Standards Regulations. There are several guidelines and regulations under FSSAI which keeps on updating, TRACC Global provides you the complete elucidation and support to be compliant.
Our Area of expertise
- FSSAI Licensing and Registration consultancy.
- Schedule IV implementation consultancy.
- Product Compliance as per FSS Food Products Standards & Food Additives Regulation.
- Labeling compliance as per Packaging & Labeling Regulation.