Product Development

CMC Project Integration

Project support designed around your goals

We deliver the full spectrum of project integration support, all designed around your business needs and goals. We’ll work closely with you to:
  • Coordinate the activities of an integrated CMC team
  • Develop timelines and budgets for global regulatory dossiers
  • Coordinate the activities of the sponsors, vendors, and consultants as subject matter experts

Why choose Alira Health?

Our team of subject matter experts support the design and development of robust, scalable manufacturing processes. They provide:

  • Coordinated, adept facilitation between clients and CDMOs
  • Experienced project management with a focus on timelines and budget for multidisciplinary CMC teams, including clients and vendors
  • Deep background in coordinating authors to create regulatory documentation for submission in line with critical timelines
  • Tailored guidance on preparation of pre-IND, IND, IMPD and BLA filings

Related news

Research & Development
Publications June 9, 2021
EU Supply Integrity Guidelines
Check out Alira Health's latest publication, “EU Supply Integrity Guidelines”. In the document, best practices for European distribution and supply integrity management are highlighted(...)
Research & Development
Publications May 27, 2021
Buffers – Navigating New Demands On Downstream Raw Materials
The COVID-19 pandemic has put unusual pressures on the supply and demand of raw materials required for the production and purification of biologics. A specific concern for the biomanufacturing(...)
Research & Development
Publications April 26, 2021
Recombinant Human Polyclonal Antibodies to Treat Disease
Congratulations to Alira Health’s Steven Chamow, PhD, Senior Vice President, CMC and founder of Chamow & Associates, and to Bryan Monroe and Chuck Olson, Senior Consultants, on their(...)
Research & Development
News March 15, 2021
Alira Health Welcomes Nikole Siegmund, Vice President, Preclinical
BOSTON, USA – Alira Health (www.alirahealth.com), a leading international healthcare and life sciences advisory firm, is pleased to announce that Nikole Siegmund has joined the firm(...)
Research & Development
Publications March 9, 2021
A Primer on Potency Assays for Release of Biologics
A key criterion in determining the quality of a biologic product is whether it has maintained its biological activity or “potency.”
Advanced Analytics Regulatory Research & Development
News November 20, 2020
Alira Health’s Ventures Portfolio Company, X-COR Therapeutics, Closes Initial $2.6M Funding Round
Alira Health congratulates X-COR Therapeutics for closing a $2.6M seed financing to continue developing its novel extracorporeal carbon dioxide removal device toward clinical trials.(...)

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