Accelerate your drug development program by leveraging our analytical development services. We create robust, phase-appropriate methods to address well-defined parameters and prepare for future drug product development activities. Our experts offer techniques and validation for solubility, dissolution, stability, and solid form definition. We’re experienced in evaluating and, if necessary, redeveloping existing methods to meet specific endpoints. Some of the analytical methods we apply include:
Our team supports you wherever your product has progressed in development, whether that means starting from scratch, improving, and expanding existing methods, or troubleshooting and fixing problematic methods. We take your current drug development phase into consideration to create the most efficient, high-quality methods for your specific needs.
We then develop a standard operating procedure (SOP) to detail the method validation process regarding the parameters, processes, and acceptance criteria that are applied. We follow protocols you provide or draft custom validation protocols to meet and comply with ICH and FDA guidelines. Our experience spans the spectrum of development, including Phase I, II, and III.
Our team is adaptable to your needs and conducts formal ICH stability studies following provided methods, compendial methods, or methods developed and validated by our labs. We use a formal stability tracking system that fully complies with the regulatory process. We outline and apply clear, well-defined release specifications to your drug product based on the quality control specifications and progression of your program.
With a diverse range of service offerings, consider partnering with us to leverage decades of experience, a state-of-the-art laboratory network, and integrated late-phase capabilities.