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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
August 5, 2025

CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines Course: Aug 5-8

Instructed by Windshire’s President and Principal Consultant, James Blackwell, PhD, MBA Certified through: The Center for Professional & Innovation & Education (CfPIE) August 5 – 8, 2025 (12:00 to 5:00 ET / 9:00 to 2:00 PT) November 17 – 20, 2025 (7:00 to 12:00 ET / 13:00 to 18:00 CET)  Join us for an in-depth course on CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines, hosted by Windshire’s president, James Blackwell. This comprehensive program is designed to provide you with all the necessary knowledge to create a CMC-compliant program for cell and gene therapy manufacturing. Don’t miss this opportunity to enhance your understanding and capabilities in the evolving field of cell and gene therapy manufacturing.   Register Now

Spotlight

A person using a stylus on a tablet navigates overlapping digital icons, including a checkmark and clipboard. The scene embodies quality by design (QbD) principles in digital task management or online project planning within a modern office setting.
3/18/2025

Quality by Design (QbD): Beyond Mere Compliance

Quality by Design (QbD) principles have been incorporated into regulatory guidelines for over two decades, so regulated life science companies are familiar with the requirements and how to meet them…

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.

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