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 19 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...
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25 years pharmaceutical industry experience with 22 years formulation development and CRO/CDMO/CMO vendor management experience at Merck (US) and MSD (China).Expertise on oral solid formulation development, analytical and clinical supply. Responsible for or supported over 30 new drug development, 5 of which were commercialized. Trained as Chemical Engineer at Lehigh Univ. (PhD) and Tsinghua Univ. (BS).
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23 years formulation development experience,21years Phase I-III formulation...
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23 years pharmaceutical industry experience in project management...
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18 years quality management experience at Eli Lily (Suzhou), Wuxi STA and Harbour BioMed. Establish and maintain the quality team and system, manage QA, QC and factory quality. Deep understanding of laboratory supervision and factory quality management. Extensive experience on quality supervision in new plant projects and quality management in product transfer.
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15 years pharmaceutical industry experience in engineering management and manufacturing management (Yaopharma in Chongqing, Joincare in Shenzhen). Responsible for facilities construction and equipment maintainance of the inhalation line in Joincare. Extensive experience in pharmaceutical facility construction. Trained in University Pharmaceutical at Sichuan University (BS）
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18 years hands-on experience on OSD development, familiar with the requirement of NCE and generic drug product, good at different dosage forms and processes, including the development of poorly water-soluble drugs, modified-release products and drug product with metastable polymorph, etc., with successful experiences of multiple projects including First-to-File ANDA product. Trained in Pharmaceutics at Shenyang Pharmaceutical University (BS) and Pharmaceutical Engineering at China Pharmaceutical University (MA).
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Over 10 years of analytical R&D experience in pharmaceutical industry at Novartis and GSK. Analytical expert for both DS and DP method development, impurity study, stability study and control strategy. Trained in Analytical Chemistry at CIAC of CAS (PhD) and Chemistry at Nankai University (BS).
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Over 14 years of experience in the pharmaceutical industry, with a focus on government affairs and CDMO business development. Specialized in driving business growth in oral formulation CDMO services for both clinical and commercial-stage drug products. Proven track record of successful collaboration with global clients across China, the USA, UK, New Zealand, Canada, and Australia. Recognized for strong sales acumen and effective leadership capabilities.
Education: Bachelor of Arts in Business English, Hubei University of Economics
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.