- Preparation of effective Responses and Corrective Actions to inspectional / audit observations.
- Comprehensive support in undertaking remediation w.r.t Warning Letter, Import Alert, Consent Decree of FDA.
- Provide tools to track regulatory commitments made to Regulatory Agencies as part of remediation plans.
- Institutionalizing Senior management reviews in Quality and Quality systems as per regulatory expectations.
- Provide sustainable solutions to complex GMP issues facing pharma companies.
INDUSTRY BENEFITS FOR
ENGAGEMENT WITH QUALIMINDS
Support and guidance coming from over 20 year experience of each of the professionals with successful track record in reputed Pharma companies.