Combination products bring together the best of medical devices, pharmaceuticals, and biologics to deliver smarter, more effective healthcare solutions
Cross-domain expertise
The regulatory pathway for combination products can be challenging due to the hybrid nature of device and drug regulations. Without a clear regulatory strategy and expert advice, overcoming these hurdles can be daunting.
We bring cross-domain expertise to support combination device development from initial strategy to final submission. Our services include regulatory strategy formulation, product classification, and comprehensive support throughout the development phase. We ensure the alignment of both device documentation and the electronic Common Technical Document (eCTD) for a successful submission.
Satisfied Clients
Explore the several ways in which we can support you:
Consultancy
We offer end-to-end regulatory and clinical support from strategy to submission.
Audits & Assessments
We perform gap assessments of combination product files, QMS assessments covering both medical device and pharmaceutical regulations.
Global Market Access
We offer support for pre-market applications in the U.S. (FDA) and IVDR conformity assessment in the EU, ranging from authoring submission documents to supporting the selection of a Notified Body, to helping during regulatory submissions and meetings with regulatory authorities.
Regulatory Intelligence
Qserve Insight will help to to stay on top of regulatory changes worldwide that may affect combination devices.
Training
We provide training on regulatory pathways for combination products.
Interim Support
We provide flexible resourcing solutions, such as interim experts, project-based support, or full functional outsourcing, to extend your team’s capabilities.
Clinical research
We support from designing and executing clinical trials to conducting PMCF surveys and writing your clinical evaluation.
Because combination devices cross regulatory categories, teams often struggle in the design process and have difficulties determining the regulatory role clarity, misaligned timelines, or incomplete documentation. This leads to increased cost, extended time to market, and a higher risk of non-compliance during review. Operational inefficiency is especially risky when regulatory interpretations evolve or authorities require component-specific justifications.
By integrating our regulatory, clinical, and quality expertise across both device and pharmaceutical domains, we ensure your project moves forward with clarity and compliance. We reduce internal complexity, align documentation with authority expectations, and help you make strategic decisions at every phase—accelerating development and strengthening your chances of approval.
Couldn't find your question?
What qualifies as a combination device?
A combination device includes both a medical device and a drug or biologic that are combined into a single product, co-packaged, or cross-labeled for use together—regulated depending on the product’s primary mode of action (PMOA).
How do I determine the correct regulatory path for a combination device?
Regulatory classification depends on principal mode of action and component integration. Our experts help determine the lead regulatory authority (e.g., FDA’s CDER or CDRH, or EMA vs. Notified Body), and guide submission strategy accordingly.
Why are audits and assessments critical for combination products?
Because authorities assess both the drug and device components, audits ensure your QMS, technical documentation, and risk management meet both sets of regulatory expectations, reducing the risk of rejection or delay.
Can you help with combination product development even if our internal teams are pharma-focused?
Yes. Our multidisciplinary consultants bridge knowledge gaps between pharma and device teams, support your regulatory planning, and ensure coordinated, compliant product development across both domains.