Simplification of GMP systems and Procedures Key to Compliance.

Effective GMP Audits to determine health of compliance for sustainability

Complexity in Procedure often leads to non compliance

Root cause analysis of failures critical to robustness of product Quality / GMP

Effective Report Writing / Documentation is as critical as Investigational Findings

Remediation

  • 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.

Mumbai Office
Qualiminds Corporate Services Private Limited,
315 Woodrow, 19 Veera Desai Road, Andheri West, Mumbai, Maharashtra - 400053. (INDIA)
HOME
VISION & MISSION
ABOUT US
SERVICES
CONTACT US