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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.