Crystal Formulation Services (CFS), a wholly owned subsidiary of Crystal Pharmatech Co., Ltd., was founded in July 2021 in Suzhou Industry Park, China. CFS provides oral formulation development and manufacturing services for innovative drug products around the world.
As a formulation CDMO,our team has rich formulation development experience developing over 100 NCEs (new chemical entities) Our management team have a track record for successful commercialization of 16 drug products. Our basis is sound science and engineering focusing on the interplay of composition design and process development. We believe in the MMM formulation development strategy, which empowers Molecule, Material and Medicine. Based on scientific excellence, we provide our clients the best formulation for clinical development, which is bioavailable, scaleable, robust, and stable. We dive deeply into oral formulation science and strive to become a first-class CDMO in this area.
To provide oral formulation development and manufacturing services for innovative drug products around the world
To be the bridge that carries the discovery molecules to their clinical trial and commercialization destinations
Patients first, Scientific and quality excellence, Meet client's needs, Protect client's IP and property
Pursued Ph.D. in Chemistry from Rutgers University,8 years at Merck...
more >24 years pharmaceutical industry experience with 22 years formulation...
more >23 years formulation development experience,21years Phase I-III formulation...
more >20 years preformulation formulation and process development...
more >23 years pharmaceutical industry experience in project management...
more >With 15 years of experience in clinical supply industry, has been the head...
more >18 years quality management experience at Eli Lily(Suzhou), Wuxi STA and Harbour BioMed...
more >15 years pharmaceutical industry experience in engineering management and manufacturing management...
more >Over 9 years of analytical R&D experience in pharmaceutical industry at Novartis and GSK...
more >Quality Policy
Our core value is patient first and maintaining high quality standards. We are committed to meet regulatory requirements for development, manufacturing, packaging, storage, testing and distribution of clinical and commercial drug products. CFS fully complies with GxP regulations, including GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GDP / GSP (Good Distribution Practice / Good Supply Practice).
Quality Management System
We are committed to build a leading quality culture to ensure that all the GxP standards are followed. We maintain data integrity with the highest code of conduct and professional standards.
We have qualified manufacturing environment, engineering utilities, processing equipment and analytical instruments, which are used for GMP manufacturing and testing.
We have established, well-structured document systems and standard operation procedures (SOPs) to meet regulatory compliance requirements.
Knowledge Management
We have an integrated organizational structure, well-trained personnel, and comprehensive technical and GMP training.
1. Blinding client’s project/compound name with CFS’s internal code
2. Using mutual-agreed shared drive for data/file transfer
1. Individual project team for each client
2. Restrict access - project files protected by password
1. IP training for new employees
2. Continuous (Quarterly) IP training, raising employee IP awareness
1. Accurate inventory of client’s material
2. Monthly reconciliation and inventory report
CFS has strong social responsibility and mission with people foremost. We are committed to a green, healthy, and safe development.
Environment, Health and Safety CommitmentStrictly follow national laws, regulations and industry standards. We pursue an integrated EHS system for our employees, enterprises and customers.