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 post-market 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, post-market 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.