ABOUT

• 25+ US Pharmaceutical Industrial Experience  in  both Brand & Generic space 

• Successfully launched more than 10 products (Solids & Parenterals)

• 15+ Years of GMP Operations Management 

• Implemented management system for CTM release to support study starts

• Upgraded stability facilities

• Implemented electronic training system

Accomplishments & Results 

• CMC Filings for NDA / IND / IMPD. 

• ANDA submissions. 

• Technology Transfer & Launch

• Stability Administration

• Formulation / Process improvement

• Technical Due Diligence

• Excipient Evaluation

• Vendor Management

• Manufacturing & Packaging of CTM

• Training development & delivery for GMP operations.