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Windshire Group | Life Science & Biopharma Consulting Solutions

Experience you can trust

The Windshire Group’s “Comprehensive Life Science and Management ConsultingSM,” and our products and solutions deliver best in class results to the regulated life science industry. We are tenaciously committed to the success of our clients.

Consulting Services

The Windshire Group are experts in pharmaceutical, biopharmaceutical development and manufacturing. Our prominent CMC (chemistry manufacturing controls) and management consulting services accelerate clinical and commercial milestones for (bio)pharmaceuticals, and increase profitability

  • Quality
  • Development and manufacturing
  • Operational excellence
    • Supply chain
    • Earned value analysis
  • Due diligence
  • Commercial planning and strategy

Products & Solutions

Our industry leading products and services for data analytics and quality management assist organizations in being more efficient and compliant

  • Continued Process Verification (CPV) Solutions
  • Stabilityshire– Stability and shelf-life data service
  • Quality management system solutions
  • Assurashire– Virtual augmented personnel support for quality management and Continued Process Verification (CPV)

Webinars & Learning

Our unparalleled learning content and webinars provide access to insights from prominent experts and increase organizational effectiveness

  • Webinars
  • White papers
  • Trainingshire– training development and consulting
  • On-site and customized training
  • Blogs
  • Expert Panel Discussions
  • Transcriptions
  • Publications
A man in a suit poses next to text promoting BioProcess International 2025, a leading conference for the bioprocessing industry. James Blackwell, PhD, is listed as a guest speaker for mastering CDMO partnerships and tech transfers in fields such as Cell and Gene Therapy. The Windshire Consulting logo appears below.
September 15, 2026

BioProcess International Cell and Gene Therapy Conference

#EVENTIMAGE September 15, 2026 – September 18, 2026 @ All Day –

Windshire Group is excited to announce ourattendance at BioProcess International, taking place September 15–18, 2026, at theHynes Convention Center in Boston, MA.

Spotlight

A pharmaceutical manufacturing facility with vials on a conveyor; text discusses the FDA AMT Designation Program for sponsors seeking expedited review, featuring graphics and the Windshire logo.
8/18/2026

Beyond Expedited Review: What Does FDA’s AMT Designation Program Actually Offer Sponsors?

Key Takeaways The FDA’s Advanced Manufacturing Technology (AMT) Designation Program, established under Section 506L of the FD&C Act, provides a framework for requesting designation of novel manufacturing methods that substantially…

Success Stories

Quote from a Principal Scientist at an Orphan Drug Development Company, praising Stabilityshires excellent customer service for its direct and timely responses, essential in the fast-paced world of drug development.
8/9/2016

Principal Scientist, Orphan Drug Development Company

I have been using Stabilityshire for consulting advice for the last year. They have consistently delivered results that are catered to my specific needs. Their reports are accurate, dependable, and…

Please reach out to find out how we can help your company succeed.

Have a quick question for one of our consultants? We’d love to hear from you.

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