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PRODUCT SERVICE
PRODUCTS
Surgical Equipment
REGULATORY SERVICES
SUBMISSION OF DOSSIERS
A. Dossiers: ACTD,CTD,ECTD and REGIONAL
PHARMACOVIGILANCE SERVICES
A. PSUR (PERIODIC SAFETY UPDATE REPORT
B. RMP (RISK MANAGEMENT SERVICES
C. PSME(PHARMACOVIGILANCE SERVICES MASTER FILE)
BIO-EGUIVALANCE STUDIES
A. IN-VIVO
B. IN-VITRO
QUALITY ASSURANCE
A. PROCESS VALIDATION
B. PERFORMANCE QUALIFICATION DOCUMENTS
C. SOPs (STANDARD OPERATING PROCEDURE)
QUALITY CONTROL
A. FINISHED PRODUCT SPECIFICATION
B. STANDARD TESTING PROCEDURE
C. STABILITY PROTOCOL AND REPORT
D. COMPLETE BACK UP
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