Expertise
Pricing
Links

"This is a quote from a happy client."

Head of Clincal Something or other - Strong Memorial Hospital

Links

We have found the following documents and websites to be useful in our work. It is our pleasure to share them with you.

White Papers

Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (PDF format)

Other Sites

CBER Guidance for CMC Human Somatic Cell Therapy INDs (PDF format)
CBER Guidance for Human Somatic Cell & Gene Therapy (PDF format)
CDER IND Application Process
CBER / CDER Phase I IND Guidance (PDF format)
CDER Exploratory IND Guidance (PDF format)