At PharmAZet the enhancement and continuous improvement of Quality is the responsibility of every individual. As part of our intent focus of our customers’ compliance needs, we conduct surveillance of new regulations, and monitor and implement new regulatory trends.
Leveraging our deep scientific expertise and proven track record, PharmAZet provides regulatory support for chemistry, manufacturing and controls (CMC) and the quality assurance services essential during all phases of drug development, including process validation and marketing applications.
We acknowledge that it is essential to offer you full range of service within our own facility thus we have opened also our own Batch Release site to provide you with Access to ALL EU territory.
Our services include:
- Gap analysis and remediation
- Preparation of CTD modules 2 and 3
- DMF preparation
- QP services
- Import documentation and licensing
- GLP/GMP audit
- Pre approval inspections – finish or API
- EUGMP/FDA CGMP
- Batch release (EUBRS) and analytical testing for batches