From Science to Compliance

 
 

Are you compliant?

 
In the chemical and pharmaceutical environment, quality assurance and quality control have to meet the high requirements of authorities and customers. Compliance with current GMP-regulations is an important factor for your business success.
 
Implementation of GMP-rules in an early-stage-development is a balancing act between high flexibility and full compliance. We can assist you in all terms of quality management.
 

Services:

 
Technical Writing
- Updating of your QM-documents, e.g. SOPs, IMPDs, etc. using your guidelines and your text format.
- Drug Regulatory Affairs support
- Support for Annual Product Quality Review
Qualification & Validation
- Qualification of analytical instruments
- Method validation
- Method transfer
 

Important links:

 
- EMEA Guideline for IMPDs (pdf, 294 kB)
- WHO validation guideline (pdf, 240 kB)
- EMEA Product quality review (pdf, 22 kB)