Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
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