Our GMP facilities are designed for large-scale manufacturing of pharmaceutical drug substances for clinical research. Manufacturing under cGMP is performed under strict adherence to U.S. FDA regulations CFR 21 parts 210 and 211 and ICH guideline Q7 for Active Pharmaceutical Ingredients. SOP's (Standard Operating Procedures) are strictly followed and meticulously documented during the manufacturing process by our trained staff of highly qualified specialists. And we provide complete documentation and regulatory support for your IND, NDA, and other regulatory body submissions.
- 1-27-09 Quality campaign (PDF - 232 KB)