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Services

Worked as US FDA agent (ID NO.: USID6969970) for domestic and international industry to market their product in USA. Effective and timely communication with FDA for all compliance related activity.

Audit And Gap Analysis

GAP Analysis ( For WHO, USFDA, EU-GMP, EDQM, KFDA, MHRA, Schedule-M,
State GMP, Health Canada, TGA, MCC,
South Africa, PMDA.

QC/QA/RA Related Activity

Preparation of Master Batch
Record, SOP’s,Monthly report,
Production planning,vessel-
Utilization report,Raw material planning.

Regulatory Affairs compliance

Regulatory filings of Generics ANDA/ANDS etc. to US, Europe, Canada, Japan, ASEAN Countries and Row market Technical Data Package Development.

Technology Transfer Activity

Technical Discussion with R & D team for the scale up of new products. Selection
of suitable equipments as per
the process suitability.

Training Programe

GMP awareness ,GLP awareness, WHO GMP awareness WHO-GMP certificate audit preparation QMS awareness ,TQM awareness Validation Utility services

Equipment Handling

Knowledge to Operate different process equipment like all type of Reactor,Tray Dryer,Vacuum Tray Dryer,Nutsche Filter,Sparkler Filter, Micron filter
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