Regulatory Affairs for Biopharmaceuticals
Diapharm offers support for biotechnologically produced medicinal products along all hurdles up to a successful marketability. Our specialists for biopharmaceuticals are the all-in-one partner to help you deal with regulatory affairs, medical affairs, analytical services and batch release. Furthermore, we take on assignments in the area of quality management and technical documentation of medical devices.
Advising manufacturers of biotechnological medicinal products is one of the key activities of the Diapharm Biotech GmbH: We coordinate and support both national and international approval and marketing authorisation procedures for a wide range of product types. From small molecules through recombinant proteins, cell and gene transfer medicinal products to viral and DNA vaccines.
Within the marketing authorisation procedure we perform all the formal and substantive work needed for applications relating to biopharmaceuticals – Scientific Advice, the Investigational Medicinal Product Dossier (IMPD), the Clinical Trial Application (CTA) and finally compilation of the complete eCTD dossier. By request Diapharm's experts can also take charge of coordinating and documenting clinical studies, GMP compliant analysis of medicinal products or batch release; this also applies to medicinal products, medical devices or combination products that have been manufactured outside the European Union. We assist in the certification of in-vitro diagnostic products and medical devices according to current regulatory and normative requirements. The European Union supports the innovative processes and plans of Diapharm Biotech GmbH.
Diapharm also supports its clients with quality management of medical devices. Together with HÄLSA Pharma GmbH, a Diapharm company, we help customers implement their quality management systems according to the harmonised standards ISO 9001:2000 and ISO 13485:2003 as well as GMP (Good Manufacturing Practice) requirements. We file the technical documentation for medical devices, coordinate CE certification and elaborate performance evaluations.
