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?

Our team has more than a decade of experience guiding companies through biologics development. As our partner, you’ll benefit from:

  • Comprehensive, integrated CMC services that deliver holistic solutions tailored to your business needs and goals
  • Knowledgeable industry leaders who deliver scalable, actionable insights
  • Close collaboration and clear communication from engagement to launch

Our locations around the globe

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