We provide full-scope Good Manufacturing and Distribution Practice Services to ensure your compliance with the relevant EU and CIS legislation.
We provide consultancy on all aspects of GMP and additional QP-services. This is an external “Qualified Person” (QP) – that is a competent person who carries out the regular work and takes responsibility in accordance with § 14 AMG on a freelance basis.
- Services of Qualified Person
- Third Party Service set up for batch release
- Quality Systems set up and review
- Writing of SOPs and other documents
- Preparations for GMP, GDP audits and inspections
- Third party GMP audits of API manufacturers
- GMP inspections arrangement from health authorities
- GMP API audit reports