Patients deserve perfection. Whether you are developing a new drug formulation or transferring your current production, there is no room for error. Our integrated team makes sure that our partners receive high quality service - bringing products to the market faster.
EFFICIENT & EFFECTIVE CONCEPT TO CLINIC TO COMMERCIAL
Pii's experts have decades of experience bringing new and current drugs into the marketplace. We make sure our production is efficient and effective, allowing us to bring life changing products to patients faster. Our regulatory support and quality assurance teams make sure that your product gets to the market as quickly as possible.
At Pii, quality is at the core of everything we do. The “c” in GMP is a constantly moving target. Because regulatory agencies and industry standards continue to evolve, we focus on exceeding “current” GMP guidelines. At Pii, we are never satisfied with where we are today but focused on meeting tomorrow’s compliance expectations.
Our team of in-house compliance and validation subject matter experts offer regulatory strategies for drug development preparation, review and submission of Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) for a variety of dosage forms and CMC sections.
Our team works closely with our partners to minimize their time commitment while maintaining the high quality of your product. Our three steps during a project lifecycle emulate how we operate throughout a partnership.
MEET THE PII SERVICES EXPERTS
“Every project, regardless of its stage of development, begins with our experienced team developing robust analytical methods to facilitate flawless tech transfer and ensure seamless quality control all the way through commercialization.”
— Monique Mendoza
Head of Quality
“We offer comprehensive regulatory services under one roof starting from CMC strategy, implementation, FDA liaison, eCTD dossier preparation and submission to health authorities through final approval and post-approval life cycle management.”
— Veeranna Lolla
Senior Director, Regulatory Affairs
“Our team’s passion will drive your program to the next key milestone by applying our expertise, collaborative style, and ability to streamline the complete drug development process.”