Regulatory: Pharma

CMC, Non-Clinical, Clinical, and PK Program Support

Our services: program support

As part of our regulatory services in pharma, the Alira Health team can:
  • Assess the pre-clinical study requirements per the indication
  • Review and analyze the drug product development and advise on formulation development, analytical testing, and validations per FDA requirements
  • Develop the clinical study plan and design of clinical studies from Phase I through Phase III

Why choose Alira Health?

As your partner, Alira Health supports your innovation, optimizing product development success every step of the way. Our integrated, collaborative teams provide a lifecycle approach to delivering our services, including:

  • Regulatory strategy
  • Regulatory intelligence
  • Regulatory operations
  • Clinical
  • Market access

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