Crystal Pharmatech

Crystal Pharmatech

制药业

Cranbury,New Jersey 5,313 位关注者

A Leading CRO/CDMO for Solid Form & Formulation, Advancing Your PCC to Phase I and Beyond with First-Time-Right Approach

关于我们

Established in 2010, Crystal Pharmatech is a specialized CRO/CDMO, excelling in crystal form and formulation services. Our exceptional track record includes supporting 1,000 clients and collaborating on over 2,000 compounds, showcasing our expertise in solid-state research, crystallization, pre-formulation, formulation development, and manufacturing. With a global presence encompassing three strategically located R&D centers in New Jersey (USA), Toronto (Canada), and Suzhou (China), we are powered by a skilled team of around 250 professionals. As a leader in both conventional and enabling formulation technologies, including amorphous solid dispersion, we take pride in our cGMP facilities, strictly adhering to the rigorous standards set by the FDA, EMA, and NMPA. Our integrated service encompasses the entire new drug development journey, from developability assessment and solid form screening to pre-formulation, formulation development, and CTM and commercial manufacturing. Introducing our pioneering Mol2Med program, designed to expedite small molecule lead compounds or preclinical candidates into Phase I and beyond, with unparalleled efficiency and precision. This 3-step First-Time-Right approach begins at the lead optimization/PCC stage: Step 1: Developability Assessment to guide API form selection and formulation design. Step 2: Solid form screening/selection and Preformulation. Step 3: Formulation development and CTM manufacturing, including packaging, labeling, and shipping to the clinical site. This innovative approach guarantees a robust API form and a scalable manufacturing process, culminating in a First-Time-Right formulation for Phase I. Streamlining the transition to future clinical studies upon Phase I success, our First-Time-Right approach sets the foundation for optimized drug development and success beyond.

网站
http://www.crystalpharmatech.com
所属行业
制药业
规模
201-500 人
总部
Cranbury,New Jersey
类型
私人持股
创立
2010
领域
salt screening、polymorph screening、cocrystal screening、API characterization、API process optimization、API crystallization、chiral resolution、preformulation、amorphous solid dispersion、formulation characterization、crystallization development and optimization、Formulation、GMP Manufacturing、Formulation Development和Clinical and Commercial Manufacturing

地点

  • 主要

    3000 Eastpark Blvd

    Suite 500B

    US,New Jersey,Cranbury,08512

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  • B4-101

    Biobay, Suzhou Industrial Park

    CN,Jiangsu,Suzhou,215123

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