Regulatory services: MIA, WDA, MS licence set up
KeyQP can offer Contract Services in relation to setting up an initial MIA, WDA or MS license in UK, EU or in India through Pharmaceutical industrial experts who have several years of experience in setting them up. We have 100% track record of setting up a new license.
We have our own MIA and WDA license in UK and Malta where we can offer loan licensing for clients who wants to have their UK or EU presence / QP Batch certification. We offer Loan Licencing for Import from Approved countries / EU to UK via approved WDA with RPI.
Our Achievements in different successful licence setup are as follow so far
- New MIA licenses set up: 7
- New WDA licenses set up: 20
- New MS licenses set up: 2
- API Plan EDQM licence set up: 2
Some of the activities we would be conducting during initial licence set up are as follow,
- Business model set up
- Preparation and implementation of Policies, SOPs, and Forms
- Setting up the facility and its Qualification to ensure Contamination and Cross-contamination control strategy compliance
- Training on basic of EU GMP, GDP, FMD, risk management and export
- Staff and management training for initial inspection handling
- Application for initial licence to regulatory authorities
- Hosting the regulatory authority audit
- Provide the audit response with evidence to regulatory authority
- Grant of the Licence
- On-going monitoring and improvement of the Quality management system