Consultation Overview
GMP Approvals & Inspections
Support for EU-GMP, USFDA, WHO, TGA, ANVISA, SAFDA, Health-Canada GCC, COFEPRIS ,Vendor Assessment Audits ,Plant Layout, Equipment, Infrastructure, Flow of Man & Material ,Validation, Calibration & Qualification ,CAPA, Risk Management, GAP Assessment (Schedule M)M QAM QC, QMS, RCA, RI, Change Control.
Service Details
What's Included
- Video consultation
- Personalized guidance and advice
- Session notes and recommendations
- Follow-up support via email
Pricing Options
- Single Session ₹3,000
- Full Project ₹50,000
About Santanu Singhamahapatra
A seasoned highly experienced in Quality operation with over a 25 plus years of relevant experience in large molecules, vaccines, biosimilars biologics industry In- depth knowledge of and ability to interpret and apply GMP, GLP, EU, FDA and ICH regulations, guidelines ,and best practices Experience in planning and conducting GMP and GLP audits . A leader with over two decades of success in managing and optimizing manufacturing & management specializing in Pharma, Biopharmaceuticals, industries
Experience
Research Consulting
Specialized expertise in research consulting with 25 years of professional experience.