Product Development

CMC Manufacturing Strategy and Operations

Strategies designed for operational success

We provide strategic guidance on the stages and costs of biopharmaceutical drug development including potency methods, such as binding assays and bioassays.

Our full spectrum of strategy and operations support features solutions tailored to your business. Our dedicated team can:
  • Develop budget and timeline estimates for preclinical development
  • Design preclinical proof-of-concept studies
  • Create manufacturing processes and oversee implementation
  • Support assay development and qualification
  • Plan and oversee execution of formulation development and stability
  • Manage reference standard preparation
  • Oversee production of toxicology and cGMP lots
  • Plan and execute GLP toxicology studies

Why choose Alira Health?

From engagement to product launch, you can rely on a dedicated Alira Health team to support the full spectrum of your drug development needs:

  • Knowledgeable industry experts who deliver scalable, actionable insights
  • Commitment to client advocacy with vendors to drive holistic solutions tailored to your business needs and goals
  • Focus on identification and execution of phase-appropriate clinical development activities
  • Strategic technical guidance, risk management, and evaluation of costs for clinical and commercial manufacturing development processes

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