Process Development
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Process Development

Process Development

We are an internationally recognized pharmaceutical CDMO company, committed to providing global customers with robust, scalable, efficient and cost-competitive process technology solutions across APIs, intermediates, registered starting materials, and excipients of all stages to effectively shorten drug development cycles and reduce risks during development.


It also saves customers R&D costs and further expands the product portfolio. With our unique experience in chemistry and engineering for over 20 years, we provide our partners with consistently safe and reliable processes.

Our Services

Our Services

Process development and optimization of innovative APIs & intermediates of pre-clinical/clinical/commercial stage

Analytical method development and optimization of Innovative APIs & Intermediates of pre-clinical/clinical/commercial stage

Integrated CMS service including process quality risk assessment and control, COI study, residual solvent assessment, elemental Impurities Analysis, and genotoxicity assessment etc.

Process safety evaluation, DSC, RC1, ARC, etc.

Development and optimization of recrystallization process to get the proper crystal form of drug substance

Treatment of highly potent compounds

Process validation and transfer

Registration support

Our Advantages

A strong R&D team with a multidisciplinary education background

Professional chemical knowledge/technology, proficient in handling various chemical reactions

Two cGMP pharmaceutical factories with state-of-the-art high-capacity equipment design and approval from FDA, EMA, PMDA, NMPA, etc.

Advanced analysis and testing instruments to promote different pharmacopoeia requirements

Special regulatory support to guide all production activities according to the latest requirements of pharmaceutical authorities

Rich experience in supporting/assisting in document preparation and submitting product registration documents to authorities

Perfect project management system to ensure that the project deliverables are provided on time in full with quality to meet customer expectations and requirements

What Can We Help You?

We provide customers with one-stop CRDMO services covering the entire lifecycle of drugs.

Introduction

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