HWI provides a wide range of services for the pharmaceutical, biotech and medtech industries, in particular for drug substances, drug products and medical devices. Our services include Laboratory Services & Quality Control, Reference Standard Services, Vigilance & Quality Services, API Characterisation & Drug Development and Regulatory Affairs Services & Life Cycle Management.

One core competence is the ability to support our clients in solving even complex development projects, including new formulation development, dossier updates, product optimisation and production transfers for medicinal products, drug-device combinations and medical devices. Clinical evaluation, assessment of biological safety and the collation of technical documentation for medical devices and drug-device combination products complete our core competences in regulatory services. Gap analysis as well as risk analysis as the first steps in development projects and the assessment of the best regulatory strategy are essential tools in our strategic approach.