CLINICAL TRIAL MATERIAL (CTM) MANUFACTURING

Executive Overview
The bedrock of drug validation. We offer unwavering support for Pre-Clinical, Phase I, and Phase II studies, ensuring seamless IND, NDA, ANDA, and 505-B2 filing. With SmaBio Labs, your clinical journey is both streamlined and fortified.
Clean Room
-
Environmentally monitored and qualified room for CTM manufacturing
-
Bench Top and Walk in Fume Hood
-
Biosafety Hood
API and Finished Product Manufacturing
-
API and FP Batch Manufacturing for Pre-clinical, Phase 1, and Phase 2 studies
-
API and FP Packaging and Labeling
-
CTM storage and Shipment to Study Sites
Release Testing and Stability Studies
-
Test Method Creation
-
Phase Appropriate Specifications
-
Issuance of COA
-
Stability Protocol
-
Stability Report
Quality Assurance and Regulatory Support
-
Thermal analysis: DSC, TGA
-
Polymorph identification and screening: XRPD
-
Particle size analysis: Laser diffraction
-
Elemental impurity profiling: ICP-MS