Combinyx Services LLC
Expert Technical Consulting for Organizations Developing Drug-Device Combination Products
About Combinyx Services LLC
Combinyx Services LLC was founded in 2026 by Jeff Givand, PhD, leveraging over 26 years of expertise from his distinguished career at Merck. He was most recently leading the R&D Device Development department responsible for clinical and commercial development of a large portfolio of biologics, vaccines and small molecules requiring delivery devices such as pen and auto-injectors, pre-filled syringes and needle-safety devices, on-body delivery systems, inhalers, subcutaneous implants, and intravitreal delivery devices.
Combinyx specializes in providing comprehensive technical and scientific consulting services to the pharmaceutical and biopharmaceutical industries. Our deep knowledge spans early R&D, delivery device technology selection, interactions between formulation and delivery device, product and process development, scale-up, process validation, registration and launch readiness. This breadth of experience and expertise across delivery technologies ranging from pre-filled syringes, to pen and auto-injectors, to inhalers, implantation and on-body delivery systems enables us to guide clients through every stage of product development and commercialization.
We exist to empower organizations navigating the complex landscape of drug delivery device design, development, and combination product commercialization. With specialized expertise in engineering, process development, primary container characterization, design verification and human factors considerations, we deliver strategic guidance that transforms innovative concepts into market-ready solutions for small molecules, biologics, and vaccines. We can help establish and pressure-test project timelines as well as product development strategies.
Our Consulting Services
Drug-Device Combination Product Development
Technical guidance for developing and commercializing combination products spanning technology selection, product and process development, validation and launch readiness yielding robustly performing products and manufacturing processes. Further guidance also provided on design verification approaches, human factors evaluations, instructions for use development and other critical combination product activities.
Program Strategy and Project Leadership Direction
Strategic guidance in the development of realistic combination product program timelines with associated strategies for execution including foreseeable execution risks. Evaluations of team composition, structure and status reviews will help ensure a more seamless execution pathway.
Team Dynamics, Partner Management and Talent Mentorship
Expert consultation on team composition, expertise and dynamics to ensure high-performing and efficient operations. Leveraging broad and deep network within the delivery device community, we can help manage and strengthen supplier, partner and CDMO relationships. Uniquely skilled and experienced in mentorship, guidance and direction of internal talent to realize full potential of the team members.
