- 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.