Quality management system
1-Estaplish/improve the quality management system QMS
2-Gap analysis for existed system, and filled the solutions required
3-preparing for audits from usFDA, EU, GCC, Saudi Arabia, Jordan and other countries.
4 -Quality by design QbD.
Prepare the protocol with all manufacturing process till fill the final report.
5- Establish pharmacovigilance system full/or minimum requirement as per the regulatory of client country.
6- Third part auditor.