Combination Products - One pillar Medzus project portfolio is the support of drug-device
combination products. Medzus has key competencies in the project management,
regulatory affairs and quality consulting for autoinjectors; pens, and needle-safety
devices.
Knowledge and experience from Medzus regarding combination products are globally
unique and make Medzus 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.