Crystal Pharmatech through Crystal Formulation Services (CFS) has poured investment into the expertise and capability of oral solid formulation technology for NCE drug product development. We aspire to be the best oral solid dosage CDMO in China, to be among the best globally, and to be the go-to CDMO for biotech and pharmaceutical companies.
CFS provides the full formulation CDMO services for small molecule oral dosage forms：
- Preformulation and material characterization
- Formulation development and manufacturing from preclinical, clinical to commercialization (including spray drying and HME)
- Integrated one-stop shop on clinical formulation development from bulk manufacturing to packaging and supplies
- cGMP and QMS meet NMPA, FDA, and EMA requirements
- Analytical and QC services
- CMC filing support
01
Preformulation and Material Science
- API Physiochemical Property
- Polymorph, Salt and Co-crystal Screening and Selection
- Solid State Research
- Excipient-API Compatibility
- Pre-formulation Development
- Formulation Risk Assessment
02
Formulation & Analytical Development
- Conventional Formulation
- Enabling Formulation (SD and HME)
- Pediatric Formulation (Mini-Tab)
- Compaction Simulation
- FFP-PMF-FMF development
- Process Scale up & Optimization
- Analytical Chemistry
03
GMP Manufacturing & Clinical Supply
- Clinical Manufacturing
- Registration Batch Manufacturing
- Commercial Manufacturing
- Clinical Stability Study
- QC Method Development
- Packaging
- Storage and Distribution
04
Regulatory Support and Other Services
- Stability Study for Filing
- Process Performance Qualification (PPQ) study
- Support IND, CTA and NDA Authoring
- Technical Consultancy on Formulation Development and FeasibilityStability Study for Filing