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CLINICAL TRIAL MATERIAL (CTM) MANUFACTURING​

Overview
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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​

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 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​

Release Testing and Stability Studies​

  • Test Method Creation​

  • Phase Appropriate Specifications​

  • Issuance of COA ​

  • Stability Protocol ​

  • Stability Report

Quality Assurance and Regulatory Support​

Quality Assurance and Regulatory Support​

  • Thermal analysis: DSC, TGA

  • Polymorph identification and screening: XRPD

  • Particle size analysis: Laser diffraction

  • Elemental impurity profiling: ICP-MS

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