Regulatory Affairs for Medical Devices
Quality assurance and regulatory affairs can hardly be dissociated from each other. That’s why Quality by Design offers you the full package.
Not only do we take care of quality management, but we also support you throughout the entire drug or medical device regulatory lifecycles.
Whether this concerns traditional pharmaceuticals, generics, vaccines, biologics, biosimilars, medical devices or Advanced Therapy Medicinal Products (ATMP), we’ve got you covered.
Overview of our RA services
Post Market regulatory
A complete Regulatory Affairs solution
Our consultants offer comprehensive knowledge and expertise when it comes to regulatory affairs. We have the knowledge and expertise to support your team or to insource full regulatory affairs projects – all in an efficient and pragmatic way.
Our Regulatory Affairs services for medical devices include writing and structuralizing registration files according to the legislation of various countries and integrating all required (technical) data.
Contact us for more information or request a free, no-obligation proposal.