There are many analytical challenges throughout the product lifecycle. Through our specialized Chemistry, Manufacturing and Controls (CMC) expertise, we deliver the highest quality data that you need to overcome them.
Reaching the Next Development Milestone
Every day is critical to reaching the next objective, whether it’s the CMC package supporting IND, NDA/BLA submission or meeting acceptance criteria for release of drug product. We not only help you reach those objectives more efficiently, we help you to understand the implications of short-term decisions on long-term goals.
Managing the Product Lifecycle
Whether you employ a minimalist or an enhanced Quality by Design (QbD) approach, demonstrating control of the product and the process throughout the lifecycle is paramount. We can help you to make the best choices of how you manage and what you spend to establish and maintain control.
Navigating the Complexity of CMC Manufacturing
CMC and the analytical package supporting it can have hundreds of different elements requiring well-coordinated capabilities and specialized expertise operating within a global quality systems framework. We deliver the most rugged, yet cost effective solution to meet the appropriate quality and regulatory standards.
Reaching development milestones faster and effectively managing your program from discovery to post-launch requires specialized expertise and end-to-end biologic solutions.
In preclinical and early clinical development, you can benefit from making us a part of your team. Together, we can create tailored solutions — including API development, preformulation, formulation, regulatory, analytical, technology transfer and IND/CTA-enabling CMC packages for all your small molecule development.