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. 
 

Contact a Biologics Expert

Our Team

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.

View Contact
Kevin McGowan, Ph.D.

Kevin McGowan, Ph.D.

Vice President, Regulatory Affairs
View Contact
Veronica Downen, M.S., RAC

Veronica Downen, M.S., RAC

Director, Regulatory Affairs
View Contact
Mehdi Kazemzadeh-Narbat, Ph.D., PMP, CQA

Mehdi Kazemzadeh-Narbat, Ph.D., PMP, CQA

Director, Regulatory Affairs

Biologics/Combination Products Services