Regulatory Fillings

1. Review of CMC Documentations
• Continuum of process development activities from
NCE selection through manufacturing
• Fundamental NCE characterization and process
development leads to meaningful control points
• Success of the scale up exercise is judged by
rational comparison of meaningful process and
product parameters
• Fingerprint parameters are identified to monitor
process robustness and used to flag issues before
control is lost

2. Guidelines of ICH & GMP
• Continuum of process development activities from
NCE selection through manufacturing
• Fundamental NCE characterization and process
development leads to meaningful control points
• Success of the scale up exercise is judged by
rational comparison of meaningful process and
product parameters
• Fingerprint parameters are identified to monitor
process robustness and used to flag issues before
control is lost

3. Completion of Vendor Questionnaires
with Zero error
• Continuum of process development activities from
NCE selection through manufacturing
• Fundamental NCE characterization and process
development leads to meaningful control points
• Success of the scale up exercise is judged by
rational comparison of meaningful process and
product parameters
• Fingerprint parameters are identified to monitor
process robustness and used to flag issues before
control is lost

4. Change Control Evaluation for
Dossier of DMF Preparation
• Introduction
• Definitions
• Types of Drug Master File
• Submissions to Drug Master File

5. Preparation of Technical Packages for
customers
• Continuum of process development activities from
NCE selection through manufacturing
• Fundamental NCE characterization and process
development leads to meaningful control points
• Success of the scale up exercise is judged by
rational comparison of meaningful process and
product parameters
• Fingerprint parameters are identified to monitor
process robustness and used to flag issues before
control is lost

6. Evaluation & Submission of query
response to queries raised by various
regulatory authority & Customers.
• Continuum of process development activities from
NCE selection through manufacturing
• Fundamental NCE characterization and procss
development leads to meaningful control points
• Success of the scale up exercise is judged by
rational comparison of meaningful process and
product parameters
• Fingerprint parameters are identified to monitor
process robustness and used to flag issues before
control is lost

7. CDSCO (Central Drugs Standard
Control Organization) documentation
USDMF submission CEP submission.