Pii’s development capabilities include modified and extended release formulations. For poorly soluble compounds, Pii offers a variety of bioavailability enhancement technologies, including solid dispersion development and lipid-or micro/ nano-based emulsions.
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Founded in 1994, Pii has grown from just 12 employees to 500 scientists and support staff and over 430,000 square feet of space in the U.S. and Europe. cGMP facilities are state-of-the-art and contain over 70 manufacturing rooms as well as containment suites for handling high potency compounds and hormones, dedicated softgel manufacturing suites, a formulation development center and analytical laboratories. Pii’s facilities have been inspected by both the FDA and EMEA and are registered with the DEA (schedules I-V).
Pii’s comprehensive offerings include drug substance optimization, preformulation testing, dosage form development, CTM manufacturing, commercial manufacturing, clinical packaging and labeling, clinical trial kit building and distribution. These services are complemented by full analytical, regulatory and project management support. Pii develops and manufactures a wide range of dosage forms covering solid, semi-solid, liquid, inhalation and parenteral. We create customized solutions to help you achieve your development goals, reduce costs and accelerate time-to-market.
With more than 400 development programs, Pii’s highly trained scientific team has extensive experience working with a variety of drug substances that have a broad range of physicochemical characteristics. Additionally, Pii’s development expertise includes immediate, modified and sustained release formulations. Each formulation is designed around the molecule’s physicochemical properties and the dosage form desired.
The “c” in GMP is a constant moving target. Because regulatory agencies and industry standards continue to evolve, Pii is focused on exceeding “current” GMP guidelines. At Pii we are never satisfied with where we are today and are instead focused on meeting tomorrow’s regulatory expectations. We are continuously investing in our understanding of regulatory requirements, adopting best practices, and maintaining our credibility with regulatory authorities. Learn more about our quality standards and systems.
Pii strives to be a reliable and flexible partner by responding and adapting to the individual needs of each client. Our role is to help our clients define, plan and execute their product development strategies. Every project starts with a thorough understanding of your expectations and project requirements. We then assemble a technically capable team dedicated to on-time delivery, constant and open communication, sound scientific principles and quality products. From project kick-off through close out, our focus is to exceed your expectations by providing a high level of customer service at every step of the development journey. Take a tour of Pii’s portfolio of services and capabilities.
Pii is a science driven contract development and manufacturing organization. We understand that designing an efficient drug delivery system is not a one size fits all approach. It is important to tailor the development process to the characteristics of the API and the development goals of the client. Pii’s access to a broad portfolio of drug delivery solutions to meet each molecule’s specific needs, ensures the right technology will be chosen to ensure long-term success. From bioavailability enhancement technologies and solid dispersion development to controlled release, our capabilities cover the spectrum of drug delivery. Learn more about Pii’s approach to product development.
People are our foundation of the service we provide. Pii’s team is comprised of seasoned industry leaders and experienced and highly educated scientists. They bring their deep scientific training and diverse backgrounds to every project and work with you to produce practical and creative solutions. It is this collective group and our collaborative culture that allows us to solve even the most challenging problems and advance your compound through the development pipeline. Learn more about the people at Pii and what makes us tick.