Welcome to TRACC Global
Welcome to TRACC Global, 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 endeavors.
We are your One Point Solution who’ll always provide you with the right TRACC.
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.
Medical Device
Assist with medical device registration, obtaining an import/ manufacturing license, clarification from the central drug standard control organization (CDSCO).
In Vitro Diagnostic
Support for diagnostic kit-related activities, including registration of notified and non-notified kits, obtaining import and test licenses, conducting performance evaluations etc.
Certification
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 Regulatory Compliance
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 Vision
Our vision at TRACC GOBAL is to be the trusted partner and industry leader in providing exceptional consultancy services for the medical device industry. We strive to drive innovation, ensure regulatory compliance, and contribute to the advancement of healthcare worldwide.
Our Mission
At TRACC Global, our mission is to provide exceptional consultancy services to the medical device industry, empowering our clients to navigate regulatory complexities, drive innovation, and bring safe and effective medical devices to market. We are committed to fostering long-term partnerships, delivering tailored solutions, and making a positive impact on healthcare worldwide.
OUR SERVICE
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.
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.
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.
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.
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.
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.
What Our Clients Says
Real feedback from our happy clients about our quality and service.
Guiding you toward global standards
We offer comprehensive regulatory support including product registration, technical documentation preparation, regulatory strategy, gap analysis, and submission assistance for domestic and international markets. Our team ensures your medical device complies with applicable standards and regulatory frameworks.
Yes. We assist organizations in establishing, upgrading, and maintaining Quality Management Systems aligned with ISO 13485 and other applicable standards. Our services include documentation, internal audits, SOP development, training, and certification support.
Our turnkey solutions cover end-to-end support — from product concept and design to regulatory approval and market readiness. We manage documentation, compliance, testing coordination, and process setup so you can focus on innovation and business growth.
Absolutely. Our experienced Subject Matter Experts provide technical guidance, audit preparation, compliance reviews, risk management assistance, and regulatory consulting to help you confidently meet industry requirements.
We offer structured design and development services including feasibility studies, design documentation, risk analysis, verification & validation support, and regulatory-aligned development processes tailored for medical devices.
Yes, we work with startups, MSMEs, and established manufacturers. Whether you are launching a new medical device or expanding into new markets, we provide scalable support customized to your business stage and regulatory goals.
Contact
TRACC Global Research and Consulting Pvt Ltd,
1271, Ground Floor, Sector-45, Gurugram,
Haryana-122001.
Mail Us
info@
traccglobal.com
Call Us
+918868886774
Latest Article
Who are we and what we do
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 SERVICE
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.
TRACC OFFERINGS
Product Development
Regulatory Compliance
Manufacturing
Turnkey Project
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.
TRACC Global SERVICES
Contact
TRACC Global Research and Consulting Pvt Ltd,
1271, Ground Floor, Sector-45, Gurugram,
Haryana-122001.
Mail Us
info@traccglobal.com
Call Us
+918868886774