Company Profile

WE PROVIDE- DOSSIER IN CTD (ALL MODULE M1 TO M5) FOR GLOBALLY, BA/BE STUDY REPORT(CO-ORDINATION), CLINICAL TRIAL REPORT SERVICES BA/ BE STUDY - BIOSTATISTICIAN ANALYSIS SERVICES AND DATA MANAGEMENT (DOCUMENT / PAPER LEVEL) DOSSIERS FOR ASEAN IN ACTD FORMAT, TOXICOLOGY STUDY REPORT / DOCUMENTS LEVEL DOSSIER PUBLICATION ECTD DOSSIER FOR LATIN AMERICA, CIS, GCC, MENA, MCC, TGA, EU CTD, RUSSIAN CTD COMPARATIVE DISSOLUTION PROFILE (HPLC- WITH CHROMATOGRAM, UV- WITH SPECTRUM) RAW DATA AND CALCULATION ASMF – DMF – DRUG MASTER FILE BIO WAIVER, RAW DATA AND CALCULATION DOCUMENTS LEVEL CLOSE PART OF DMF DOCUMENT LEVEL PHARMACOVIGILANCE / PATIENT SAFETY UPDATE REPORT / RISK MANAGEMENT PLAN ( PVG/PSUR/RMP ) CLEANING VALIDATION DOCUMENTS LEVEL ( CV ) MASTER FORMULA RECORDS ( MFR/MFC ) BATCH MANUFACTURING RECORDS ( BMR ) SUMMARY OF PRODUCT CHARACTERISTICS & LEAFLET ( SPC & PIL ) STANDARD OPERATING PROCEDURE ( SOP ) SITE MASTER FILE ( SMF ) ANNUAL PRODUCT QUALITY REVIEW ( APQR ) BIO- ANA