Welcome to the Official website of TRACC Global

About TRACC

We TRACC Global are your go to medical device solution.Our commitment to excellence extends beyond product development. Collaboration is at the core of our ethos.

Reach Us

business@traccglobal.com

+918868886774

TRACC Global Research and Consulting Pvt Ltd, 1271, Ground Floor, Sector-45, Gurugram, Haryana-122001

Who are we and what we do

We are your One Point Solution who’ll always provide you with the right TRACC.

View all services

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.

OUR SERVICES

At TRACC Global, we take pride in our diverse range of horizontal capabilities that enable us to offer a comprehensive suite of services throughout the entire product lifecycle. From conception to manufacturing, our unified approach and holistic solutions ensure that we meet our client’s unique requirements and exceed their expectations.

REGULATORY SERVICES

Quality Management System

TURNKEY PROJECT SERVICES

Our Approach

🔻

At TRACC Global, we bring a comprehensive, partnership-driven approach to regulatory and compliance consulting. Our mission is to make complex certification and compliance processes seamless and effective, enabling our clients to bring safe, high-quality products to global markets confidently. From facility setup to regulatory approvals, we’re with you every step of the way.

A Comprehensive Support for Entire Product Life Cycle

We offer end-to-end support throughout the entire product lifecycle, which is a rigorous and coordinated effort. Our comprehensive services encompass research and development, manufacturing, marketing, sales, customer services, and end-of-life management.

Exclusive Bulk Reagent Customized Supplies

We provide reagents in bulk that are customized and tailored to the specific needs of a particular research project or application. They may be designed to have specific chemical properties and purity.

Raw Material Customized Supplies

We provide the raw material manufactured or sourced to meet the exact specifications provided by the customer, ensuring that the end product is of desired quality.

Artwork and Labeling Services

We offer artwork and labeling services, which are an essential part of product branding and marketing. This helps in creating a professional appearance for your product, ensures brand consistency, complies with regulations, saves time and money, and ultimately helps to increase sales.

TRACC Global SERVICES

WE PROVIDE

Regulatory Services

Impact assessment, remediation, and maintenance of regulatory files.
Indian MDR 2017 Compliance regulatory support and Local authority submissions.
CE- IVDR and MDR Compliance regulatory support.
WHO PQ Compliance regulatory support.
Regulatory Trainings.
Consultancy services for Device Registration in any country: - Thailand, Vietnam, USA, UK, etc.
Technical File, Dossier, DMF preparation assistance.