We
Understand what
You VALUE
Quality
& Time
with
Exceptional Resources
Temple’s QA/RA program
is nationally recognized
Assurance of Quality and Timely Delivery
Pre-clinical & Clinical Trials cGMP Manufacturing
Capsules Powders Placebos
cGMP Facility
Our Mission and Our Passion is to deliver safe and effective
medicines as quickly and efficiently as possible. By leveraging our
renowned scientific and regulatory support we deliver customized
solutions to our clients. We will provide comprehensive services
from formulation and development, to regulatory filing and effective
technology transfer.
The Resources and Facilities to Deliver
• Pre-formulation
– Solubility Testing
– Ka Determination
– Initial Method Development
– Partition Coefficient Determination
– Prototype Development/Assessment
• Formulation Development – Prototype Formulation Development
– Stability Assessment
– Packaging Assessment
• Technical Operations • Technology Transfer
• Method Transfer • Scale-up • Process Development
• Process Validation • Cleaning Validation
Temple cGMP Services
Director: David
B. Lebo R.Ph., Ph.D
Temple University School of Pharmacy
3307 North Broad Street
Philadelphia, PA 19140
Phone 215-707-5895
Fax 215-707-3678 david.lebo@temple.edu
