Unlocking the secrets of analytical services: An insider interview with colman byrne

About Colman Byrne

Colman Byrne received his education from Trinity College Dublin. Prior to joining DSI, Colman had worked at Charles River Labs, Eximias, Cardiokine in increasingly responsible analytical development, regulatory, quality and operations roles. At CRL, Colman was responsible for managing a cGMP laboratory performing chemistry, bioanalytical and analytical biochemistry testing on various chemical and biotech dose forms. At the subsequent organizations, he helped coordinate the activities of analytical and bioanalytical CMOs, and provided support with regulatory filings and API manufacture. With over 40 years of industry experience, Mr. Byrne is the most senior Analytical Services expert at DSI. Colman is technically proficient in all aspects of analytical services having spent years managing both contract laboratories and the AR&D groups at pharma and biopharma companies.

About DS InPharmatics 

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.

In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.

French-headquartered ProductLife Group (PLG) is well-known in the Life Sciences market. It has a track record of successfully managing global outsourcing programs and insourcing services for its international client base. The company is on a mission to help transform human health outcomes by optimizing regulatory affairs, safety & vigilance, and quality compliance for life sciences organizations worldwide.

The fit between our two organizations could not be more perfect. We will complement PLG's growing biotech services portfolio. US biotech sponsors recognize DSI as a leader in consulting for go-to-market strategies and RA pre-market consulting. At the same time, PLG has a strong reputation for managing end-to-end outsourcing of regulatory affairs and pharmacovigilance activities worldwide.

Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database - as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements.

We see enormous potential in this new chapter for DSI and you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we're incredibly excited to add our momentum to that effort.

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