Formulation Development

First-Time-Right 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 cdmo 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 and 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 pharmaceutical 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

If you want to know more about drug formulation services, please visit our website.

We can provide professional cro service for clients, anything you need, please contact us.