-横版-原色.webp "Crystal Pharmatech Co., Ltd."){kind=logo}
_800x800.webp "Solid Form Development CRO and Formulation CDMO Services for Small Molecule Drugs")
Crystal Pharmatech is a global solid state CRO and formulation CDMO specializing in solid form development, preformulation, formulation
development, and GMP manufacturing for small molecule drugs.
With an average of over 20 years of technical expertise, our team has successfully supported 100+ early-phase programs and 19 commercialized
products globally.
Our M3 Philosophy (Molecule . Material- Medicine) integrates clinical requirements, API material properties, and formulation science to guide
development decisions. This framework enables scalable solutions that advance small molecule programs efficiently from discovery through
commercialization development decisions. This framework enables scalable solutions that advance small molecule programs efficiently from discovery through commercialization.
Integrated CRO and CDMO capabilities supporting small molecule programs from early candidate evaluation through clinical development and commercialization.
Our M3 Philosophy integrates clinical requirements, API material properties, and Quality-by-Design (QbD) formulation principles to guide development decisions. This framework connects molecular understanding with material attributes and product design to enable scalable solutions from early development through commercialization
Clinical requirements and therapeutic goals
DMPK understanding
Pharmacodynamic profile
Safety and toxicology considerations
Molecular characteristics
API physicochemical, biopharmaceutical, mechanical properties, and stability
Excipient functionality, physical attributes, and compatibility
Formulation properties designed for manufacturability
Target product profile guiding formulation design
Interaction of formulation composition and manufacturing process
Impact of API and excipient properties on critical quality attributes (CQA)
Impact of critical process parameters(CPP) on product quality
Control strategy for drug product performance
Over 20 years of average scientific experience supporting more than 100 early-phase programs and 19 commercialized products worldwide.
Focused expertise in solid form development, crystallization process development, and formulation strategies for complex small molecule compounds.
Seamless CRO and CDMO services supporting small molecule programs from solid form research and formulation development through clinical and commercial manufacturing, fully compliant with FDA, EMA, and NMPA regulatory standards.
Comprehensive drug substance and drug product characterization using advanced techniques including XRPD, ssNMR, SCXRD, MicroED, DSC, and TGA.
__Benefits,_Applications,_and_When_to_Use_It_in_Drug_Development.webp "What Is Amorphous Solid Dispersion (ASD)? Benefits, Applications, and When to Use It in Drug Development")
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