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Tunnell Consulting Strengthens Regulatory Affairs Team with Addition of Industry Veteran Kati Abraham

Tunnell Consulting has been solving the most complex problems faced by life sciences companies for over 50 years. One of the biggest challenges faced by life sciences, biotech and pharmaceuticals companies today is in interpreting the complicated regulatory environment. Joining the firm’s regulatory affairs services team is Kati Abraham, who is well known in the industry and brings significant high-level expertise to the table to assist the firm’s clients in their regulatory journeys.

With more than 30 years of experience, Ms. Abraham has end-to-end regulatory experience ranging from pre-IND through BLA submission and lifecycle management, ushering new products into the pipeline, and developing compliance infrastructures for clinical sample testing laboratories.

“Every member of the industry is facing increased regulatory pressures, at every phase of their process,” said Maryann Gallivan, CEO at Tunnell Consulting. “Kati’s years of experience and deep understanding of the regulatory process has already proven an essential component in achieving regulatory success for our clients, and in getting their life sciences products to market faster.”

Ms. Abraham’s background includes experience in developing and managing cross-functional teams to develop, negotiate, and implement successful regulatory strategies for challenging products and to align them with real-world business goals. She has a solid background in direct interactions with the FDA and other regulatory bodies. Prior to joining Tunnell, she worked both in start-ups and in big biopharma, and held senior positions at Merck & Co. and GSK, as well as serving as Vice President, Regulatory Affairs at VaxInnate Corporation, where she was responsible for developing and executing regulatory strategy for products at all stages of development.

“Tunnell Consulting’s footprint in the biotech and pharma industries represents a perfect fit for me,” said Ms. Abraham. “I’m pleased to be able to join this group of experts as they help guide their clients through the minefields of regulation, overcoming barriers and gaining approval for new life-saving technologies.”

Tunnell Consulting’s regulatory services begin at the evaluation stage, running from drug discovery to market approval. In addition to supporting the full range of regulatory submissions and serving as liaison to regulatory authorities, Tunnell provides expert leadership to internal project teams and works with management to create specific and effective regulatory strategies.

About Tunnell Consulting
Founded in 1962 and serving many of the world’s leading life sciences firms and government agencies, Tunnell Consulting, Inc. integrates strategic, technical, process, and organizational skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientific credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve. To learn more, visit us online at

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