2018-03-21T12:38:43
Pharmacovigilance consultant in Delhi
DCGI, CDSCO, Drug, Medical Device, cosmetic Registration/ license Consultant in India
Drug regulatory services India
Drug and cosmetic act
Drug regulations India
Drug Registration Delhi
CDSCO Drug Registration consultant
Drug/device/cosmetic import License services in India
Food License in India
CDSCO India
Drug import in India
Dossier Compilation for Emerging Markets/EU/US/Australia
Types – eCTD, ACTD, NeeS, National Filing
Preparation and filing of documents IND, NDA and ANDA
Dossier conversions to CTD/ACTD for Drugs & to CSDT for Medical Devices
CPP, DMF Reviews
FDA/DCGI liaison meeting
PIL User Testing
API filing with EDQM for obtaining CEP
Product label maintenance
Import Licenses Registration
PV
Pharmacovigilance consultant
Pharmacovigilance services in EU, USA, India, Russia CIS countries
PVG modules, European Medical Agency
Pharmacovigilance guidelines USFDA
Adverse event reporting, ICSRs E2B reporting
Clinical trial reports
Medical device related reports
Literature reports
Aggregate & Periodic Report Writing
PSURs, PBRERs, PADERs, DSURs, Bridge reports, Annual safety reports etc.
Signal detection & Management
Risk Management Plans (RMPs), REMS
PSMF, QPPV (Qualified Person for Pharmacovigilance)
PV audit and inspection
Clinical Trial Monitoring
Clinical Project management
Clinical Trial Set-up
Regulatory Affairs for Clinical Trials
Patient Safety/Pharmacovigilance in Clinical Trials
Clinical Data Management
Clinical Biostatistics Services
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