Medfiles offers comprehensive analytical services for chemical and microbiological analyses. Our laboratories have a GMP licence and GMP certificates. Method development, validation and transfer for various analytical techniques with complete documentation according to current regulatory guidelines belong to our strong areas. Comprehensive quality control analytics as well as batch certification by QP of drug substances, excipients and finished products, also for re-analysis of pharmaceutical products for the EU market are part of our laboratory service portfolio.
In our adjustable humidity- and temperature-controlled GMP laboratory with multiple built-in vacuum lines we perform comprehensive analytics for inhalation products, both DPIs and MDIs. Medfiles offers pharmaceutical product development services all the way from early clinical phases to marketing authorisation, for both human and veterinary pharmaceutical products. Our GMP license covers also to manufacturing of Investigational Medicinal Products (IMPs) for clinical trials. We perform stability studies according to the ICH/VICH guidelines and additional tailor-made studies according to clients’ needs. Technology transfer and industrialisation services are an essential part of the complete laboratory service package offered by Medfiles.
Medfiles offers client-tailored R&D solutions and laboratory services such as:
- Formulation development
- Production of IMPs
- Chemical & microbiological analyses
- Analytics of inhalation products
- Stability studies
- QP, Quality & distribution
- Technology transfer & industrialisation
- Pharmaceutical documentation