Clinical Trial Drug Safety Service | Pharmacovigilance

Drug Safety

Drug Safety and
Risk Management

End to end services for various pharmacovigilance aggregate reports for more than a decade across all regions including US, EU, Japan, China and other APAC countries.

End to end services for various pharmacovigilance aggregate reports for more than a decade across all regions including US, EU, Japan, China and other APAC countries.

End to end services for various pharmacovigilance aggregate reports for more
than a decade across all regions including US, EU, Japan, China and other APAC countries.

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Differentiators

Global Pioneer in DSUR’s

First DSUR submitted by SIRO IN 2011, within 30 days of ICHE2F guideline implementation

Over 500 DSURs submitted with no queries from health authorities

Core experts in Risk Management Plan

Specialized team for EU and Core RMP to leverage efficiencies in authoring, technical review and QC for all types of regulatory submissions

Dedicated experts across all major Therapeutic Areas

Proficient across all major Therapeutic Areas, scientific review of aggregate reports by team of specialized physicians

Innovation

Day minus 90 implementation of aggregate reports

Experience in SOP and template development for various safety reports adhering to regulatory guidelines

Document Types

Case Studies

DRUG SAFETY AND RISK MANAGEMENT CASE STUDY 1

RSI consolidation for a Vaccine DSUR.

DRUG SAFETY AND RISK MANAGEMENT CASE STUDY 2

Country-specific DSUR.

DRUG SAFETY AND RISK MANAGEMENT CASE STUDY 3

DSUR for Co-developed product.

DRUG SAFETY AND RISK MANAGEMENT CASE STUDY 4

Major EU-RMP Update with consolidation.

DRUG SAFETY AND RISK MANAGEMENT CASE STUDY 5

Dynamic cross deliverable assignments for multiple safety reports.