 |
Facility Construction and Start Up |
| Technology/Process/Product Transfer |
|
CMC Development |
|
Clinical Trials Material Management |
|
Validation
 |
Process & product |
|
Facilities & equipment |
|
Analytical and bioanalytical methods |
|
|
Compliance Systems Development |
|
Quality Systems Tracking
|
CAPA (i.e. deviations, investigations, etc.) |
|
Change Control |
|
Documentation |
|
Training |
|
|
Contract Supplier Management for
|
Contract manufacturers of drug substance (API) and drug
product (final dosage forms) |
|
Contract labeling and packaging providers |
|
Contract laboratories for
 |
GMP release testing |
|
GLP preclinical studies |
|
GCP central laboratory testing |
|
Bioanalytical testing from GLP or GCP studies |
|
|
