Pii is an end-to-end CDMO supporting the development, FDA approval, and cGMP manufacture of a wide range of dosage forms, from parenterals, aseptic fill-finish and terminal sterilization to oral liquids, soft gels and controlled release oral suspensions, tablets and capsules.
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Whether you have a complex parenteral dose form, aseptic fill-finish project, a challenging oral solid dose need, or new complex regulatory affairs strategy, Pii has what you need in an excellent outsourcing partnership – proven experience, relentless commitment, and the highest integrity.
Pii is pleased to announce an expansion of our sterile manufacturing operations specifically focused on delivering high-quality, small and medium batch aseptic fill-finish efficiently and on accelerated timelines.
Our new fully-robotic GENiSYS® R filling machine utilizes single use technology and pre-sterilized, ready-to-fill vials, syringes and cartridges in strict accordance with cGMP requirements.
For more than 25 years, Pii has been supporting customers across the entirety of their product development and manufacturing programs. Proven know-how and focused resources in product development save you time and pay dividends all the way through the development and approval process to commercialization.
Transparency, dedication and integrity are cornerstones of our approach to every partnership, and our commitment to every project is unwavering – as you will experience from our engaged teams throughout our organization.
Pii offers development and cGMP manufacturing services for liquid, suspension and lyophilized parenterals, oral liquids, suspensions and solids, including hormone, high-potent (HPAPI) up to SafeBridge® Category 4, cytotoxic drugs and DEA Schedule I-V controlled substances.
Our experienced scientists and leadership team has been on both sides of the outsourcing equation and understands the unique needs of each customer. What’s more, our top people are fully engaged and accessible to you – we listen first to your needs and priorities and give you a personal pledge that our team will deliver for you.
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