MCRA advises leading biologics companies throughout the device lifecycle.
Bringing Biologics & Combination Products to Market
Biologics have the potential to bring hope to millions suffering from a wide range of diseases. However, this field of study remains in its early stages, with much yet to be learned. Companies that want to bring these revolutionary products to market face stiff challenges from a number of fronts. Not only do they need to conduct thorough clinical trials to ensure they will work as intended, but manufacturers also need to be careful as they wade through the complex regulatory environment.
Our Experience in Biologics & Combination Products
Fortunately, the biologics experts at MCRA are here to help. 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. We provide exhaustive expertise in practically all areas of biologics consulting, at every point of the product lifecycle. With our experience in biologics and combination devices working by their sides, our clients have found success introducing a wide range of innovations to the market, including:
- 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 in biologics and combination products consulting 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.
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.
Biologics & Combination Products Resources
Biologics/Combination Products Services
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Biologics/Combination Devices Clinical Research Organization (CRO)
Our biologics consulting group supports our clients throughout their journey to the marketplace with our proven expertise, world-class facilities, and dedicated team of professionals. From biological testing services to biological risk assessment and more, our clients come to us because they know we will leave no stone unturned for them.
Learn more about our biologics/combination devices CRO services here.
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Biologics/Combination Devices US Regulatory
With our help, devices will be guided through the complex FDA regulatory process thanks to our specialized knowledge and experience. Clients know they can trust our biologics consulting expertise to help them navigate the challenges of regulatory compliance.
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Biologics/Combination Devices Global Regulatory
We deliver strong regulatory and scientific leadership so medical devices can be brought successfully through various international regulatory processes. No matter where they want to go, our biologics compliance solutions make certain no doors are left closed to them.
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Biologics/Combination Devices Reimbursement, Health Economics, and Market Access
Bringing more than 50 years of experience when it comes to reimbursement, health economics, and public policy services, we are a full-service resource. Ensuring consistent revenue streams is critical no matter what the product, and our biologics and combination product expertise ensures every relevant option will be explored in full.
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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. We understand how important it is to have absolute faith in a product before introducing it to market, and our biologics consultants make it possible for our clients to have it.
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Biologics/Combination Devices Healthcare Compliance
Expect our consultants to deliver complete expertise when it comes to navigating today’s complicated legal and regulatory landscapes. Our extensive knowledge of the ins and outs of compliance prevent costly hang-ups during the development process for combination medical devices and safeguard patient safety.
Learn more about our biologics/combination devices compliance assistance here.
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Biologics/Combination Devices Cybersecurity
Protecting advanced medical devices from cybercrime and data breaches is of the utmost importance today, and we bring the experience to do that. We ensure biologics tracking solutions remain secure and safe even as they use patients’ data.