We at Symeres pride ourselves on a stellar track record in drug-substance development. For our clients that are looking to rapidly move through phase-appropriate clinical tablet formulation development, Exemplify is the perfect place to start for small-scale to large-scale pharma companies. Our cGMP suites are specially equipped to support everything from pre-tox formulation to first-in-human (FIH) trials and commercially ready formulation.
From the patient perspective, tablet formulation provides convenience in terms of medication storage, ease of administration, and for taking medicine on the go. Furthermore, solid formulations like tablets tend to stabilize most molecules better than dissolved or suspended drugs in liquid forms. Our expert team at our Cranberry site has demonstrated successful formulation flexibility in transitioning from Phase 2 solution formulation to commercially viable Phase 3 tablet formulation, with strategies that withstand FDA scrutiny and accelerate successful commercialization.
Exemplify is able to evaluate and optimize the performance of a client’s product using in vivo clinical data to direct formulation design in real time. This integrates formulation development, GMP manufacture, and clinical supplies in parallel to streamlining drug development and setting the client on a reliable path to commercial success.
Additionally, our team not only develops and produces smaller early-phase clinical supplies and scales up to larger later-phase trials, but also offers full validation support and has much experience with technology transfers if the client decides to transfer it to any commercial production site across the globe. Therefore, if you are looking for express development and expertise in NCE molecule development, NDA 505(b)(2), and ANDA development programs, then our Cranberry site is the perfect place to start.
Exemplify utilizes the knowledge of our scientists to solve any problems through innovation, speed, and flexibility, offering excellent value for companies needing better R&D outcomes in tablet formulations of drug products.
