Head of Analytical Services
With over 30 years of industry experience, Mr. Byrne is our 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 AR&D groups at pharma and biopharma companies. This includes both biologic large and synthetic small molecules, raw material release testing, HPLC, GC, and TOC testing, protein/peptide sequencing, API manufacturing processes, lipid-based product testing, and various forms of drug product testing, and support of combination products.
Colman provides oversight to other internal analytical team members, he directly supports clients in all the stages of development. Using his technical ability in conjunction with his knowledge of submission requirements, he not only supports an initial filing effort but also the technical defense of a submission (information requests, in person Regulatory Agency meetings, and annual report updates).
- Expert reviewer, setting and justifying release specifications or determining the most suitable method for an existing product
- Deep hands-on knowledge of methods and experience with contract labs and proven invaluable to clients.
Colman received his education from Trinity College Dublin. Prior to joining DSI, Colman has worked at Charles River Labs, Eximias, Cardiokine in increasingly responsible analytical development, regulatory, quality and operations roles. At CRL Colman was responsible for a lab of over 10 people managing cGMP laboratory testing including chemistry, microbiology, cell culture, particulate counting and identification, biocompatibility testing and animal facilities.
- Method Development
- Agency Meeting Advice
- Strategic Planning
- Regulatory Submissions
- Due Diligence
- Experimental Design/DOE