Our highly trained and expert regulatory affairs staff and scientists will accelerate your drug (NCE) or biologic (NBE) from preclinical testing through formulation development and clinical supply utilizing QbD principles.Contact
Pii provides insight and support of your clinical formulation development and clinical and commercial supply management — all while exceeding the FDA regulatory hurdles along the way. With proven expertise ranging across all sterile and oral dosage forms, Pii will lead you through the entire process accelerating your decision-making through every step of the way. Our team-based approach and seasoned project managers will ensure you have transparency and well-thought-out options at each step of the transition from product development to CTM to commercialization. Our campus in Hunt Valley, MD, seamlessly integrates R&D, regulatory affairs, manufacturing and analytical laboratories to deliver your product using Quality by Design (QbD) principles on time and accurately the first time.