Dedicated to innovation and your success!
Senita Consulting is committed to supporting Emerging Biopharma companies in navigating complex global regulatory requirements.
Our customized solutions simplify the intricate regulatory landscape, addressing each client's specific needs. With deep regulatory expertise, we craft effective strategies to expedite market entry for innovative products.
Additionally, our network of specialist consultants offers complementary expertise, further enhancing our capabilities.
We can help.
True innovation and development of novel technologies rarely happen in larger companies nowadays.
But they do in Emerging Biopharma!
Kathrin Schalper
Kathrin has close to 25 years of experience spanning many settings, including assignments with blue chip pharma, emerging biopharma, and consulting. Over the course of her career, Kathrin has held roles of increasing responsibility in Regulatory Affairs and R&D Project Management at Avalo Therapeutics, Epizyme, Halloran Consulting Group, Accenture, Allergan, Novartis, and Bayer. During her tenure in the consulting industry, Kathrin led the North America Regulatory Affairs team at Accenture and established the strategic R&D advisory function at Halloran Consulting Group.
Kathrin currently serves as our Principal Consultant, Regulatory Affairs, and Managing LLC Member. She often functions as an on-demand Head of Regulatory Affairs and Project Lead. She advises on regulatory strategy and integrated development planning to drive the development of clients' assets and platform technologies.
Kathrin teaches at the University of Southern California (Los Angeles), serving as adjunct faculty for various programs in Regulatory Sciences, Management of Drug Development and Health Care Decision Analysis. She is also a regular contributor to Regulatory Affairs Professional Society's (RAPS) Fundamentals of Regulatory Affairs series and other publications.
Kathrin is a certified Project Management Professional (PMP) and holds a Ph.D. in Pharmaceutical Sciences.
Principal Consultant
Matthew Thomas
Director of Operations and Project Management
With over 25 years of experience in regulated industries, Matthew is a seasoned professional with an understanding of the regulatory affairs landscape. Currently serving as the Director of Operations and Project Management at Senita, Matthew is pivotal in ensuring streamlined business operations, working closely with Kathrin to drive growth and success.
Matthew's career trajectory began as an independent Laboratory Technician, where he quickly demonstrated his leadership qualities and passion for excellence. From there, he worked his way up the ranks to become a Laboratory Director, overseeing every aspect of laboratory design, construction, and certification.
As a Laboratory Director, Matthew also took on the challenge of identifying and training suitable candidates up to industry compliance standards. Due to his efforts, his laboratory received accreditation and quickly became highly productive, exceeding client expectations for professionalism and quality.
Throughout his career, Matthew has consistently demonstrated a talent for developing, reinventing, and optimizing key laboratory processes and systems, resulting in maximum efficiency for the industry. With his expertise in compliance, and strong organizational and leadership skills, Matthew is an asset to any team seeking to navigate the complex regulatory landscape and achieve success.
