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
21 years of pharmaceutical research experience, including 8 years at Merck Research Laboratories and Merck Manufacturing Division
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26 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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25 years formulation development experience, 21years Phase I-III formulation development experience at Merck (US)
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23 years pharmaceutical industry experience in project management...
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20 years quality management experience at Eli Lilly (Suzhou), Wuxi STA and Harbour BioMed.
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16 years experience in GMP manufacturing and engineering management at Yao Pharma in Chongqing and Joincare in Shenzhen China.
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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
18 years hands-on experience on oral formulation development, familiar with both NCE and generic drug products. Specialized in different dosage forms and processes, including poorly water-soluble drugs, modified-release products and drug product with metastable polymorph, etc., Successfully delivered multiple projects including First-to-File ANDA products and NCEs. Trained in Pharmaceutics at Shenyang Pharmaceutical University (BS) and Pharmaceutical Engineering at China Pharmaceutical University (MA).
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13 years pharmaceutical industry experience with over 10 years of analytical R&D experience 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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With 15 years in pharmaceutical preformulation and solid-state development, he established relevant labs and built integrated R&D platforms. Specialized in novel crystal forms for NCEs and generics, experienced in project initiation, R&D management, patent filing/maintenance, and regulatory strategy design. Trained in Pharmaceutics at Peking University (BS) and Pharmaceutical Engineering at National University of Singapore (MA).
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.