Formulation Development

In Crystal Pharmatech, instead of one-size-fit-all platforms or “super-placebo” or quick and rough “fit-for-purpose” formulation approaches in early development, we apply a “First-Time-Right” strategy for formulation development to accelerate your molecule to First in Human (FIH) studies and onward to commercialization at a cost-effective and time-saving way.

Crystal Pharmatech boasts a formulation development leadership team with extensive experience and deep expertise and has built a state-of-art formulation pilot plant and labs, which are equipped with world-class manufacturing equipment and R&D instruments. We strive to provide you with the best formulation development approach and become the trusted internal partners to support each step of your project to:

• “First-Time-Right with Line-of - Sight”: Speed up into First in Human (FIH)

• Enhance bioavailability and improve solubility

• Optimize API

• Improve timelines and save costs

• Path forward formulation recommendation

• Design, validate and implement analytical process

• Collect IND filings data

A well-designed formulation should have appropriate bioavailability, good physicochemical, biological and microbiological stability, and a robust manufacturing process. Biding by the molecule-material-medicine, dubbed the M3 drug product development philosophy, we design and develop a formulation tailor-made for a molecule to meet its intended clinical needs, with good bioavailability, stability, manufacturability, patient compliance and regulatory acceptance while avoiding significant formulation change from early to late development. 

Analytical Chemistry Services 

Crystal Pharmatech has considerable experience in analytical chemistry. We offer a comprehensive range of integrated, high-quality, efficient and effective solutions using advanced methods and instrumentation and problem-solving skills.

• Analytical Method Development and Validation

• Product Release

• Stability Study

• Compatibility Study

• API-Excipient-Packaging Release

Benefits: 

• Highly quality guaranteed

• Advanced instruments

• Full services

• Short cycle time