Combination Product Development & Regulatory Services
We offer comprehensive combination product development services that cover the entire product lifecycle — from concept and design through manufacturing, regulatory submission, and post-market surveillance. Our integrated, end-to-end approach helps streamline development, reduce risk, and ensure full compliance with FDA, EMA, and global regulatory requirements.
Our Combination Product Expertise
- Early-Stage Development
Define user needs, create design concepts, and develop a strategic roadmap for successful combination product development. - Regulatory Strategy & Submission
Navigate complex global regulatory pathways with expert guidance on product classification (drug-led or device-led). We prepare and manage regulatory submissions for the FDA (CDER, CDRH, CBER), EMA, and other authorities, ensuring compliance with MDR, ISO 13485, and cGMP requirements. - Design & Development
Execute iterative product design, establish manufacturing processes and test methods, perform human factors engineering, and manage risk throughout the design lifecycle. - Testing & Validation
Comprehensive analytical testing, design verification and validation, biocompatibility testing, stability studies, and sterilization validation to ensure product safety and efficacy. - Manufacturing & Quality Systems
Support for medical device manufacturing, assembly, and packaging in cleanroom environments. We perform process validation and implement robust Quality Management Systems (QMS) to maintain regulatory compliance and product integrity. - Post-Market Services
Full lifecycle management, including post-market surveillance, quality audits, and adverse event reporting, to ensure ongoing safety and regulatory compliance.
Our holistic, cross-functional services bridge the worlds of pharmaceuticals, medical devices, and biologics—helping you bring innovative combination products to market faster, with confidence and compliance.