Regulatory Affairs Reimagined
Regulatory Services Tailored to Emerging Biopharma
Simplifying the complex regulatory landscape
Senita Consulting’s mission is to empower Emerging Biopharma companies to overcome the challenges of navigating complex global regulatory requirements and bring life-changing, innovative biopharmaceutical solutions to patients with unmet medical needs more quickly and efficiently.
Customized Services
Regulatory Strategy and Development
Assistance in crafting a comprehensive regulatory strategy customized to your product and providing a roadmap to guide you through the regulatory landscape.
Orphan Drug Designation
We support clients in developing drugs or biological products to prevent, diagnose, or treat a rare disease or condition by facilitating the orphan drug designation (ODD) process.
Expedited Program Designations
Guidance on selecting the most suitable expedited program for your product and offering assistance in evaluating your product as well as navigating the designation process.
Labeling and Target Product Profile
We are knowledgeable about the most recent regulations for labeling and best practices to develop target product profiles and can help you identify what will work best for your product.
Health Authority Meetings
Serving as your representative when meeting with health authorities, accompanying you through all stages from planning to interactions with the agency,
Marketing Applications
We help our clients navigate, develop, and defend marketing applications, including New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAA).
IND and CTA
We work closely with our clients to implement the most appropriate strategy for achieving approval from the US FDA and other regulatory authorities.
US Agent Services
We facilitate FDA communication for our non-US clients, serving as the intermediary. Recognized by the FDA as equivalent to the sponsor, we manage document reception and promptly address urgent inquiries, ensuring effective and seamless interaction.
Expertise
Offering comprehensive expertise spanning various therapeutic areas and product types, along with strategic advisory services.
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Cardiovascular
Dermatology
Endocrinology and Metabolic Disease
Gastroenterology
Hematology
Immunology
Neurology / CNS
Oncology
Ophthalmology
Pediatrics
Psychiatry
Respiratory
Rare Disease
Rheumatology
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Small Molecules
Gene Therapy
Cell Therapy
Monoclonal Antibodies
Oligonucleotides
RNA Therapeutics
Cancer Vaccines
Nanomaterials
Glycomimetics
Combination Products
Why Senita?
At Senita, you'll find a dedicated regulatory partner accompanying you every step of the way.
Kathrin Schalper and Matthew Thomas established Senita recognizing the need for unconventional approaches in the face of innovative technologies.
Our enduring success lies in our ability to challenge conventional regulatory pathways and seamlessly collaborate with Biopharma development teams to pioneer novel solutions.
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Principal Consultant
Kathrin Schalper has close to 25 years of experience spanning many settings, including assignments with blue chip pharma, emerging biopharma, and consulting.
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.
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 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.
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Director of Operations & Project ManagementWith 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.