Aquestive is a proven and trusted provider of development and manufacturing services to industry partners. We offer customized solutions to meet a wide range of development needs and processes, from product formulation through commercialization. We design development plans by merging innovation with a thoughtful, risk-controlled approach to product development and regulatory reviews. We take a full-lifecycle view of a product and use our in-house knowledge and capabilities to tailor processes from project inception to completion — working with partners along the way to maximize the value proposition of an asset.
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Our highly skilled and experienced formulation team, with wide-ranging in vitro and ex vivo screening capabilities, guides prototype selection to optimize desired product performance attributes.
Analytical R&D informs all aspects of product quality and performance throughout a product’s lifecycle. Analytical methods inform the formulation development process, guiding product attribute decisions and de-risking prototype selection for clinical studies. Methods are designed and validated to be robust, discriminating, and transferable for use in quality-controlled laboratories.
Our tech transfer engineers harness product development knowledge to implement approaches and processes for risk-management. The use of scalable equipment throughout product development allows for the identification of scale-dependent and scale-independent variables that are verified through designed experiments prior to registrational batch manufacture.
Our preclinical function interfaces with well-respected clinical research organizations (CROs) to predict product performance throughout the development process.
Aquestive’s clinical team oversees the design and execution of studies to assess the performance of development candidates and marketed products. Our clinical operations team collaborates with study management organizations and investigational sites to assure efficient, high-quality execution of clinical programs, reliable data collection and analysis, and accurate documentation of product and usability data.
Aquestive’s Regulatory team is well-versed in the unique regulatory challenges and opportunities presented by drug development with PharmFilm® technology. The team works seamlessly to set the standard for quality, safety, efficacy, development, and manufacture of products for our patients and community.
Aquestive has built a commercial team to support strong market access, sales, and uptake of novel and improved central nervous system (CNS) products. Experienced professionals bring knowledge and relationships from prior work on pharmaceutical product launches and expanded indications. For partners with commercial-ready or late-stage CNS assets, we offer the ability to expand key opinion leader (KOL) relationships, speaker bureaus, and interactions with specialists in neurology practices to support successful commercialization.
