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

Regulatory Affairs

  • Preparation of dossiers and submission of Drug Master Files, ANDAs, Market Authorization (MA) applications.
  • Deficiency responses of dossiers – ANDAs, DMFs, MAs, handling all regulatory queries.
  • Regulatory pathway for CBEs, PAS, Supplements, Annual updates, Variations.
  • Regulatory filing in semi-regulated markets.
  • Regulatory approvals from DCGI, CDSCO, State FDA.

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)
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