MCRA advises leading biologics companies throughout the device lifecycle.
Our Experience in Biologics & Combination Products
Equipped with a superior knowledge base and deeply experienced management team, MCRA is well-positioned to help clients overcome the scientific and manufacturing complexities of biologic and combination product development.
- Recombinant Proteins for Bone Growth
- Platelet Rich Plasma
- Point of Care Devices that Process Biologics
- Cellular Products for Regenerative Medicine
- Hyaluronic Acid
- Drug Delivery Systems
- Adhesion Barriers
- Bone Void Fillers
- Tissue Engineering
- 361 HCT/Ps
We’ve become one of the most trusted names in the industry because our biological consulting and clinical research are based in strong expertise and offer the widest range of capabilities. We serve our clients by providing them everything they need to bring their biologics and combination products to market. Our offerings include expertise in global regulatory support, clinical research organization services, reimbursement and market access, quality assurance, healthcare compliance, and cybersecurity.
Our aim is to provide best-in-class services when it comes to bringing biologics and combination products to market. We help our clients with their product development and commercialization goals, making the process as smooth and painless for them as possible. Our experts stand by their sides throughout the innovation process, from developing the basic concept through pre-market development and finally to widespread market use. We’re committed to making sure the most advanced medical technology finds its way to the people who need it the most. This passion is the fuel that drives everything we do for our clients.
Providing regulatory strategy and all the other expertise needed to see biologics and combination products to market requires a lot of experience, skill, and leadership. Fortunately, our in-house biologics experts deliver these and more to our clients. Meet our team of dedicated and experienced professionals within this specialty below.
Kevin McGowan, Ph.D.
Veronica Downen, M.S., RAC
Mehdi Kazemzadeh-Narbat, Ph.D., PMP, CQA
MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System
MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Porous PEEK Cervical Interbody System
MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry
Biologics/Combination Products Services
Biologics/Combination Devices Clinical Research Organization (CRO)
We support our clients throughout their journey to the marketplace with our proven expertise, world-class facilities, and dedicated team of professionals.
- Biologics/Combination Devices US Regulatory
Biologics/Combination Devices Global Regulatory
We deliver strong regulatory and scientific leadership so medical devices can be brought successfully through various international regulatory processes.
- Biologics/Combination Devices Reimbursement, Health Economics, and Market Access
Biologics/Combination Devices Quality Assurance
Clients know they can count on us to keep track of all document control, R&D, risk management, software development, supplier evaluation, measurement equipment control, and other processes.
Biologics/Combination Devices Healthcare Compliance
Expect our consultants to deliver complete expertise when it comes to navigating today’s complicated legal and regulatory landscapes.
- Biologics/Combination Devices Cybersecurity