Knowledge and experience from confinis regarding combination products are globally unique and make confinis a valued partner of numerous pharma-, biotech-, biosimilar- and medical technology companies, ranging from startups to global industry leaders. It does not matter whether the combination products are prefilled syringes with or without a needle safety system, auto-injectors, pen-injectors, inhalers, stents or drug-eluting patches.
With some customers we are closely involved from the definition of the user requirements until the postmarket surveillance, whilst with others we help develop the regulatory strategy or the design control procedure. Our consultants have hundreds of years’ worth of hands-on experience. This allows us to offer a uniquely broad and in-depth range of services.
Our range of services encompasses regulatory affairs, quality management (21 CFR Part 4), design control, risk management, usability engineering/human factors, clinical evaluations, labelling, production, process validation, supply chain, postmarket surveillance, auditing and training. In addition, we develop our own innovative approach to the modular construction of Design History Files (DHF), which enables a quantum leap in the maintenance of DHFs.
Why choose us?
confinis is a valued partner. It does not matter whether the combination products are prefilled syringes, with or without a needle safety system, auto-injectors, pen-injectors, inhalers, stents or drug-eluting patches.
