First-In-Man Phase I
Pii can accelerate your path to clinic. We understand a company's need to do more with less. Whether your constraint is time, budget, or limited supply of API, Pii will design a development program customized to meet your goals. Early phase services include:
Screening different solid forms
Characterizing and selecting the best candidates for development
Developing early phase fit-for-purpose formulations
Manufacturing cGMP clinical materials
Providing analytical services, methods development, validation and stability programs
Pii can take your API from pre-formulation to clinical supply release in an accelerated timeframe and we offer a variety of strategies to expedite product development for first-in-man studies.
A major barrier to the advancement of many NCEs is their poor solubility. To address these difficult to formulate compounds, Pii offers a comprehensive portfolio of drug delivery solutions.