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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 and regulatory
  • 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
Bio International Convention
#EVENTIMAGE June 3, 2024 - June 6, 2024 @ All Day -

We are thrilled to announce that Windshire’s esteemed President and Principal Consultant, Dr. James Blackwell, PhD, MBA/MS, will be attending the highly anticipated Bio International Convention in San Diego from June 3-6, 2024. Dr. Blackwell eagerly anticipates this opportunity to engage with fellow attendees, sharing insights into Windshire’s specialized expertise and services, and exploring potential collaborations to further our mission of innovation and excellence in the field.

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Spotlight

european flag

Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials

Addressing quality requirements of an investigational medicinal product for a given clinical trial without sharing your company’s overall development strategy…

Success Stories

CEO of E-submissions and EDMS Integrator

ARCC services and products are a huge time and money saver that our organization depends on, year in and year…

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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