Due to the Europe-wide regulation of the production of pharmaceuticals, there are binding regulations according to the so-called "Good Manufacturing Practices" (GMP).
We will accompany your application procedure with the competent authority, provide you with a tailor-made quality management system, train your employees and help you to implement it in practice. In doing so, we also support you in the selection of possible service providers as well as in the preparation and follow-up of the inspection and its accompaniment on site.
We offer you:
- Support with the application according to §13 AMG
- Compilation of the necessary documents (for manufacture and testing according to the state of the art in science and technology)
- Establishment of a quality management system according to the type and scope of your activities in accordance with §3 AMWHV or EU-GMP Guidelines Part I, Chapter 1
- Preparation of the Site Master File according to EU-GMP guidelines part III
- Qualification of the supply chain
You already have a manufacturing license and need help?
We offer you:
- a comprehensive process analysis (analysis of your quality-relevant activities)
- GAP analysis of your QM system and the complete quality-relevant documentation
- Ensuring regulatory conformity and timeliness ("inspection readiness")
- Creation of an individual action plan
- Monitoring the implementation of the necessary measures