COMPANY OVERVIEW

We are an end-to-end Global Quality Compliance Services Provider to Pharma, Biotech, Medical Device & Tobacco companies.

Compliance Group works closely to help our customers succeed through documented evidence of the fulfillment of qualification, compliance and validation protocols. Our bottom line is helping our customers meet the precise standards of the FDA, EU Annex, and ISO with our experienced and skilled team supported by technology and domain partners.

We are the only Technology/Service Provider representative in FDA Consortium that is comprised of a coalition of large Pharma and FDA agents. As a result, we bring to the table the most up-to-date thinking from the agency, often saving millions of dollars for our customers

Compliance Group is run by a team who are at the cutting edge of developments in Compliance. The team is supporting mid-size and large Life Sciences businesses across the world. Engaging us will not only ensure your timelines are met but will also result in contributions from our organizational assets – i.e. working knowledge and solutions based on the latest Compliance trends from FDA Consortium.

Whether you are in need for a little guidance or looking for outsourced delivery models, Compliance Group can customize the solution and the appropriate delivery model that fits your specific situation. 

WHY COMPLIANCE GROUP?

  • Innovative Solutions

  • Deep Experience

  • FDA Partnership

  • Access to Valuable Resources

  • Strategic Alliances

Compliance to:

  • FDA – 21 CFR Parts 820, 210, 211, 58, 11

  • EU Annex 11, 93/42/EEC, 98/79/EC

  • ISO 13485, 14971, 19011

 

KEY DIFFERENTIATORS

World class Organizational Assets

All of our services include our IP & Organizational Assets (e.g. Expert Advisory & Consulting including FDA Consortium Members, Training Sessions, CoE Templates & Knowledge Base) – at no additional cost.

Straight from the FDA Consortium

We are the only Technology/Service Provider representative in FDA Consortium that is comprised of a coalition of Big Pharma and FDA agents. As a result, we bring to the table the most up to date thinking from the agency, often saving millions of dollars to the clients.

Independent, Specialized Services

Compliance Group’s core mission and specialization is providing independent validation services. This means our only aim is to ensure our clients remain compliant in a rapidly changing technology and regulatory landscape.

Rapid Scalability

Compliance Group’s excellent resource utilization methodologies and India/US/EU recruitment engines position us to rapidly deploy resources for any of our capabilities.

Cost Efficient Solutioning

We offer GAMP 5 Risk Based Approaches and leverage guidance from FDA consortium that are proven, low cost solutions.

Siemens Channel Partner

Solutions partner of Siemens in Application Lifecycle Management (ALM) space.