Quality Assurance
We provide full-service quality consulting services to support the development, implementation, and maintenance of right-sized, stage-appropriate Quality Management Systems (QMS) for our clients.
We support you with the following measures:
- Monitoring your projects
- Building up your quality systems
- Contacting medicines authorities for you
- Helping you in obtaining a manufacturing authorisation
- Advising you about applications for marketing authorisations for medicinal products and APIs (CEP/DMF)
Daily Business Support for GMP Projects
Our staff is on site 40 hours a week, integrated in your teams and completing the work according to your specific directions. This way you benefit from an efficient support in all your GMP matters by professional and qualified personnel for a defined project.
Possible Services:
- PQR development and preparation
- Preparation of stability reports
- Complaint handling
- Batch Record Review
- Quality deficiency reports
- Release preparation
- SAP change management
- Change request control
- Review of marketing authorisation documents
- Qualification and validation
- Organization of documents (signature, filing)
- Individual support for a QP
- Further issues in the day-to-day business