Full complex support within Quality Assurance Compliance from QP services, EU Batch Release to complex certification of EU GMP by EU Authorities.
The enhancement and continuous improvement of Quality is the responsibility of every individual. As part of intent focus to our customers’ compliance needs, we conduct surveillance of new regulations, and monitor and implement new regulatory trends.
We acknowledge that it is essential to offer you a full range of service within our supervision. Our own Batch Release Site is set to provide you with access to whole EU territory.
Our services include:
- Gap analysis and remediation
- Preparation of eCTD modules 2 and 3
- DMF preparation
- QP services
- Import documentation and licensing
- GLP/GMP audit
- Pre-approval inspections – finished drug product or API
- EU GMP
- Batch release (EU BRS) and analytical testing for batches