Services
Product Development
- Formulation Development for Oral and Topical Semi-Solid Dosage Forms
- Controlled Release Delivery of API
- Improving API Stability
- Tablet coating
- Taste/Odor Masking
- Optimizing Production Cost
Analytical Services
- Method Development and Validation
- Degradation Studies
- Dissolution Method Development
- Cleaning Validation
- Raw Material Testing
Regulatory Support
Electronic Submissions (eCTDs)
- Paper Applications (CTD)
- Structured Product Labeling (SPL)
- Establishment Registration
- Drug Listing
- U.S. Agent Services
CGMP Manufacturing Services for Nutritional and Pharmaceutical products
- API Compounding and Fill Into Capsules
- Manual and Automated Encapsulation
- Wet Granulation/Tray or Fluidbed Drying
- Tablet Compression and Coating
- Packaging of CTM for IND, NDA, or ANDA Clinical Studies
- Stability Studies
- Topical Dosage Form (Semi-Solid, and Liquids)
- GMP Suites