Product Development

CMC Manufacturing Strategy and Operations

CMC Manufacturing Strategies that Succeed

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 for CMC Manufacturing?

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

CMC Manufacturing News

News June 17, 2022
Music Beats Cancer Hosts Reception at BIO International Convention in San Diego
Music Beats Cancer hosted a reception fostering a networking community for innovators working on promising solutions for cancer.
Crowdfunding Patient Centricity Research & Development
Events May 9, 2022
7e Journée start-up innovantes du dispositif médical
Clinical Digital Health Market Access MedTech Research & Development
News April 5, 2022
Alira Health Strengthens Clinical Operations with the Acquisition of Sourcia
We acquired a full-service Contract Research Organization (CRO), Sourcia, that provides services for Phase I to Phase IV clinical trials with a focus on biotech, medical devices, and(...)
Clinical MedTech Patient Engagement Pharma Regulatory Research & Development
Publications December 10, 2021
Data Intelligence for Opportunity Screening and Prioritization in Drug Discovery
Our biotech client needed an innovative, effective way to identify which binding sites and therapeutic indications they should target for the development of new therapeutic agents for(...)
Advanced Analytics Digital Health Pharma Research & Development
Events November 24, 2021
Event: Innovations In Wound Healing Annual Conference
Join Dr. Mitch Sanders for an exclusive poster session at this event.
Research & Development
Events October 20, 2021
Event: SAWC Fall 2021
Join Dr. Sanders at SAWC Fall in Las Vegas, NV.
Research & Development
Publications August 18, 2021
Infographic: Indication Prioritization and Pre-Commercial Value Assessment
Download our infographic on Indication Prioritization and Pre-Commercial Value Assessment.
Due Diligence Research & Development
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