Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
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Cell & Gene Therapy Post-Approval Solutions
1. Supported the development of
BOTH
GENE
REPLACEMENT
THERAPIES
FDA approved
CAR-T therapies and helped
advance the first 2 FDA-approved
Real-World Evidence Studies
& Post-Marketing Commitments
Long-term follow-up studies
Disease and product registries
Global presence; deep therapeutic area expertise
~25 Project Managers
Database of 200,000 physicians worldwide
Contacts with regulatory and payers in
key markets
Access to policy, fee schedule payment data
and decision makers
Patient Safety Pharmacovigilance
1,300+ safety professionals across the U.S., Europe and Asia Pacific
200+ person team of highly experienced safety writing professionals
120+ member team of medical reviewers–case review, aggregate
review and signal management
PV SMEs available locally in each region to provide guidance in
global and local regulations
CELL GENE THERAPY
Post-Approval Solutions
With specialized expertise, coordinated capabilities and focused
investments across preclinical, clinical and post-approval phases, we’ll help
you to reduce the time and risk in your product’s development.
Processed
in the last
5 years
From intake
and case
processing
automation
Regulatory compliance
achieved in the last 4 years
~2.5M 55% 99.5%
CASES TIME
SAVINGS
Across all product therapeutic areas