K Prabu Kumar
Senior Manager Regulatory Affairs at Symbiotec Pharmalab Pvt. Ltd.,Indore, Central India
- Role
- Senior Manager Regulatory Affairs at Symbiotec Pharmalab Limited
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About K Prabu Kumar
Registration of API in USA, Europe, Canada, Australia, Japan and ROW countries - eCTD Lorenz docubridge - Variations, annual reports, audit support, change controls - Highly versed with computers (Lorenz eCTD docubridge, eCTD Builder, Chem Draw, ISIS Draw and Bliss Q systems )- Review of API Drug Master Files (Module 1, 2 & 3). Specialties: eCTD (XML backbone) submission to USFDA, Health Canada, TGA Australia, EMA, to European member states. CEP to EDQM. Review of documents required for Regulatory submissions
Experience
Senior Manager Regulatory Affairs
Oct 2018 — Present · Indore, IN
Education
Pioneer Kumaraswamy College, Vettoornimadam, Nagercoil - 629 003.
Bachelor's degree, Chemistry
1999 — 2002
Annamalai University
MSc, CHEMISTRY
2002 — 2004
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