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THE HEARTLINE GROUP

QUALITY AND COMPLIANCE PARTNERS FOR COMMERCIAL SUCCESS

Project Management

We understand the need professional project management as it is imperative to operating successfully in highly regulated industries.

Regulatory Affairs

Understanding regulations and how they apply to your company does not have to be a cumbersome activity. We assist with the intricacies that come with the regulations.

Quality and Compliance

Quality is not a department it is a mindset and compliance is not optional. We work with companies, CAPA, ..

Startup's

The Heartline Group’s staff has successfully navigated numerous companies through FDA inspections both domestically and internationally where the consequences of an actionable inspection could prevent product commercialization.

Compliance

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About Us

Quality and Compliance is the lifeline to Medical Device and Pharmaceutical product success. Products take years to develop and get to the market. The landscape for the path from conception to commercialization can be obscure and daunting. The Heartline Group is her to partner with your business to identify your gaps, help you develop a compliance plan to remove them, and work with your leaders to develop successful long-term solutions for success. 

Our consultants have a minimum of 20 years of relevant industry experience in the areas of medical device, cell therapy, virology, Development, Regulatory Affairs and Engineering. 

Our News

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Make your Appointment Today