Compliance with EN ISO 13485 and GMP
The increasing co-operation of medical device manufacturers with pharmaceutical companies makes it necessary to approximate quality management system according to EN ISO 13485 to GMP requirements.
Valicare`s long-standing experience within the medical device, biotechnology, and pharmaceutical industry allows us to detect and implement necessary extensions in the quality management systems of our customers. Our services are based on international laws and regulations such as EU GMP guideline, 21 CFR (FDA) with cGMP, Guidance for Industry documents (FDA) as well as GHTF, PIC/S, ICH Guidelines and GAMP 5.
Our specially designed concepts cover:
- GMP auditing & consulting with Gap-/target-actual analysis
- GMP upgrade
- „In house“ GMP starter and expert trainings
- Good documentation practice
- Establishment of training courses
We offer you a comprehensive service in order to implement the mandatory quality standards in development, manufacturing, packaging, storage, and logistics of your medical devices, companion diagnostics, and combination products which could include advanced therapy medicinal products.