Resources › United States
Resources
At WellSpring, we wish to assist you every step of the way. For more information on U.S. clinical supplies, regulations, or other related topics, please see the links provided:
- FDA Website: Website
- Clinical Trials Phases: wikipedia
- Good Clinical Practices: Website | Download PDF
- cGMPs for Finished Pharmaceuticals: Website
- cGMP for Phase 1 Investigational Drugs: Download PDF
- 21 CFR Part 320 — BA and BE Requirements: Website
- BA and BE Studies for Orally Administered Drugs: Download PDF
- Safety Reporting Requirements for IND and BA/BE Studies: Download PDF
- 21 CFR Part 312 — IND Application: Website
- Computerized Systems used in Clinical Investigations: Download PDF
- General guidelines for Process Validation: Website
- SUPAC — IR/MR Solid Oral Dosage Forms: Download PDF
- SUPAC — IR Solid Oral Dosage Forms. CMC In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Download PDF