Integrated Pharmaceutical Research and Development
Recognize the unique chemical, pharmaceutical, and business attributes your compounds have to offer with our services. We understand that bringing a pharmaceutical product from late-stage discovery to commercialization requires experimentation and integration of interdependent disciplines. Our experienced team offers streamlined drug development capabilities to support your programs at all stages.
Partnering with us means choosing an integrated services partner, which includes preformulation screening, formulation, and process development through clinical supply manufacturing and beyond. Our team spans across a network of nationwide laboratories, providing you with a broad range of services to meet your unique needs.
Our approach to API development is comprehensive, considering each molecule’s solubility, stability, degradation pathways, solid-state properties, and biopharmaceutical properties. As a result, we streamline the rational formulation, process development, and drug product manufacturing processes by integrating these different datasets.
Driving Forward Drug Substance Selection
Characterize and analyze the critical properties of your molecule with our preformulation studies. By assessing how your drug behaves under various conditions and environments, you make more informed preclinical development decisions and narrow down which candidates have greater odds of success, saving time and money in the long run.
Progress your drug substance during preclinical research by optimizing the product formulation and developing materials for further testing. Whether you face challenges with the dosing vehicle or simply need preclinical dosing supplies, our team is here to help.
Gain targeted insights with custom bioanalysis performed by our team to support lead selection and optimization. We offer comprehensive quantitative bioanalytical services across different drug development stages in parallel with our other analytical, formulation development, and manufacturing capabilities.
API Development & Drug Product Optimization
Create and utilize robust, stage-appropriate analytical methods to address well-defined parameters and prepare for subsequent activities in pharmaceutical product development. Our experts provide analytical development techniques and validation to inform your downstream experiments, with a focus on solubility and dissolution, stability, and solid form definition.
Produce optimal drug product formulations within the boundaries informed by preformulation characterization data, including solid form, solubility, stability parameters, and target pH range. Our strategies withstand FDA scrutiny and accelerate successful commercialization.
Go beyond traditional process development by utilizing our team’s pharmaceutical specialty technologies. We enable successful formulation and developability for drug products when traditional approaches have proven insufficient. Our expert team understands that choosing the right technologies can be challenging and are ready to help you find the right tools for the job.
Overcome complexity and variability in clinical trial drug manufacturing by partnering with our highly experienced team supported by state-of-the-art facilities. Our flexible solutions prioritize preserving your available material and bringing your compound to market faster while meeting all current quality, health, and safety standards.
Safeguard your drug product’s quality and delivery to the end user with our trusted clinical packaging, labeling, and kitting services. With our assortment of advanced technologies and manual capabilities, we ensure your project seamlessly transitions into the clinic. We treat each product with the time and attention it deserves to achieve the highest quality possible, no matter the scale.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.