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First In Man Fast Formulations

During the early phases of development, Pii understands a company’s need to do more with less. Whether your constraint is time, shrinking budgets, or limited supply of API, Pii will design a development program customized to meet your goals. We offer several strategies to expedite product development for first in man studies, including:

Pii has the experience and capabilities to help you reach those critical first in man milestones quickly and cost effectively. Early phase services include:

  • Screen different solid forms
  • Characterize and select the best candidates for development
  • Develop early phase fit-for-purpose formulations
  • Manufacture cGMP clinical materials
  • Analytical Services, including QP release

When You Need More

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. From softgels and liquid/lipid filled hard gel capsules, to hot melt extrusion and spray dried dispersions, Pii has the tools required to meet each compound’s specific needs and challenges. Read More»

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