Capabilities
We have the experience necessary to take a drug through the FDA process to final approval.
We have successfully accomplished this already as our IPLEX™ product was approved by the FDA in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion, who have developed neutralizing antibodies to GH.
Clinical/Regulatory Experience
- Post Marketing Safety Surveillance
- Phase I - IV Clinical Studies
- Pre - Clinical Studies
Analytical Experience
- Product Characterization
- Method Development and Validation
- Clinical Sample Analysis
