The Medpace Combo: Drug-Medical Device Combination Products
Our dedicated medical device CRO is embedded within the global Medpace clinical research organization providing greater knowledge, better coordination, and a holistic approach to your clinical development for combination products.
Medpace brings a holistic and integrated approach to drug-device combination product approvals with its own “combination” that provides a unique advantage: a dedicated medical device division combined with the global Medpace biopharmaceutical clinical research organization. We combine medical, regulatory and operational experts from both drug and device perspectives into a collaborative team that understands the nuances and global landscape of each side. With this specialized combination of expertise, we can help you determine the best regulatory pathway to accelerate the approval of your drug-medical device combination or drug delivery product.
Navigating Regulatory Complexities
Determining if your combination product will be subject to drug regulations, device regulations, or both can be complicated. Medpace can provide strategic leadership to define the optimal regulatory pathway from a global perspective including:
- Guidance on how to best classify your product, supported by a thorough understanding of applicable regulatory guidance and standards from the US and Europe
- Understanding of the type and amount of clinical data needed
- Addressing post-market requirements early to prevent costly problems after the product is on the market
- Specialized knowledge in Advanced Therapy Medicinal Products (ATMPs) as borderline products
Combination Products
- Regulatory strategy development to facilitate path to market of combination products with drugs, biologics and medical devices
- Assessment of the product’s primary mode of action (PMOA) and determination of product’s classification and regulatory pathways
- Gap analysis to fulfill applicable regional and country-specific regulatory requirements
- Guidance to create an integrated clinical and regulatory strategy to enable product development to meet clinical milestones
- Scientific and strategic support for regulatory document development and interactions with Regulatory Authorities and Notified Bodies
