|
Submission Development & Support:
|
| |
• |
PDi can successfully develop, compile and support regulatory submissions (ANDS, CTA) or post-approval submissions (SNDS). |
|
| • |
PDi utilizes its network of experts for protocol design, clinical trial project management, and integrated study report writing. |
|
| • |
PDi provides in-house expertise on most aspects of chemistry and manufacturing documentation development and submission (CMC and DMF). |
|
| • |
PDi has experience in preparing electronic submissions. |
|
