Preclinical – Phase I
Early-phase pharmaceutical development programs often experience challenges unique from those of later phase and commercial programs. Navigating the complex regulatory landscape requires experience to effectively design, develop and collect high-quality data prior to an IND submission, such as material characterization, solubility, product stability and safety. When you find the right development partner, you increase the likelihood of advancing your product.
Cambrex is here to support you in your early-phase program. Our development experts apply their ingenuity, technical skill, and experience to find creative solutions suitable to your needs. At every stage, our experts work closely with you in a collaborative partnership, while providing effective project management open communication and transparency.
Our state-of-the-art facilities support the following services for early-phase programs:
IND Enabling Services
With Cambrex, you gain access to cutting-edge technologies combined with highly experienced industry professionals to support the needs of your IND filing.Learn More
We take a proactive approach to early-phase pharmaceutical process development and apply our expertise and creative problem-solving skills to optimize your chemical process.Learn More
Our dynamic formulation development services will adapt to your early-phase challenges as the needs arise. Our scientists have the experience and knowledge to help you advance.Learn More
Solid State Characterization
Our veteran team of solid-state chemistry experts will work with you to address your unique early-phase development challenges and help you achieve your specific goals.Learn More
By offering a comprehensive suite of analytical testing services, we can support development, validation and testing for your program, whether it’s early-phase, late-phase or commercial, and ensure your materials meet the highest standards for safety and quality.Learn More
We offer extensive microbiology services at our FDA-registered facilities, which are fully compliant with all GMP and GLP testing services and standards.Learn More
Stability Storage & Testing
We offer complete stability storage and testing services at all phases of development, including commercial programs.Learn More
Drug Substance Manufacturing
We provide lab-scale and kilo-scale manufacturing for pilot API scale-up for pre-clinical material and for phase I clinical trial material, including all the analytical support required to reach early-phase regulatory milestones.Learn More