Pharmaceutical
- New Drug Submissions
- Repackaging Pharmaceuticals
- Produce OTC Formulations
- Perform Early Stability and Non-Human Clinical Studies for IND Submissions
Medical Device
- Manufacturing Scale-up
- Device Assembly and Kitting
- Sterile Device Management
- FDA Initial Import Services
Regulatory
- New 510(k) Submittals
- FDA Submissions
- PMA Submissions
- Assistance With GMP Issues