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Client Projects-The Windshire Group

QMS, CMC, Regulatory, Process Development, Biopharmaceutical Manufacturing Projects.

The Windshire Group’s consultants have worked for small to multi-national clients, for all major therapeutic classes at all stages of the product life cycle. Representative projects include:

Auditing/Quality Systems

  • Performed a “For Cause” audit of two critical European suppliers to resolve an urgent OOS (out of specification) issue
  • Performed mock-PAIs for a client’s critical supplier
  • Supported a prominent third-party to a Consent Decree
  • Wrote procedures and policy for setting specifications for a developing company
  • Reviewed environmental monitoring practices, procedures, and training for gaps and risks. Recommended and implemented remediation plan.

Chemistry, Manufacturing and Controls (CMC)

  • Performed a CMC gap assessment, ranked risks and made recommendations that were pivotal to client meeting PDUFA date
  • Assisted a client in responding to FDA CMC questions and concerns regarding the client’s analytical studies and data using for an extended release oral NME by expediting new studies and assisting with response letter
  • Performed person-in-plant duties to oversee CMO and manufacturing for a campaign
  • Provided an expert witness for a prominent law firm for an industry lawsuit
  • Researched and oversaw identification of a drug product CMO for an oral dosage drug product CMO
  • Assisted with selection of a CMO for a commercial biological

Conceptual Design and Owner Representation

  • Designed a conceptual facility for a cell therapy product, including capital cost estimates, project timelines and technology recommendations

Operational Excellence

  • Developed and assisted with implementation of Earned Value Analysis (EVA) as a method for integrating various projects within a development program and measuring performance throughout live cycle of programs
  • Assisted with implementation of EVA for development portfolio analysis and management


  • Performed gap analysis of an array of analytical methods for a complex cell therapy process
  • Reviewed IND and assisted with method tech transfer for personalized medicines company
  • Identified gaps in analytical development and validation for an oral dosage form, provided extensive assistance in addressing an FDA concern and implemented a new method to meet an aggressive PDUFA target


  • Assisted in formulation improvements for a commercialized oral dosage therapeutic


  • Assisted client in rapidly troubleshooting complex commercial vaccine manufacturing issues
  • Performed an analysis of CMO options, and worked with CMOs to identify best fit for client’s drug product manufacturing
  • Performed due diligence on a novel biologics production system for a potential investment
  • Assisted a client in resolving compression issues for two of their oral dosage products
  • Assisted a client on a visit to an Indian API supplier to assess process changes, supply chain and regulatory impacts
  • Performed a root cause investigation, including a statistical analysis of the historical performance of a critical unit operation and discovered an unexpected root cause
  • Researched and identified a global metrology solution for a commercial company with global operations
  • Researched and identified potential sites for processing and manufacturing in Europe

Operational Excellence

  • Implemented Earned Value Analysis (EVA) as a method (using Planisware) for integrating various projects within a development program and measuring performance throughout life-cycle of program 
    • Provided consistent, uniform method of communication to all stakeholders on budget, performance, and project/portfolio status
    • Significantly improved program performance
  • Developed a global supply chain strategy, including global third-party logistics (3PL) for a newly launched product

Conceptual Facility Design 

  • Developed conceptual design for personalized medicine cell therapy processing facility
    • Performed feasibility and value engineering of initial design, doubling capacity with only a 40% increase in project cost


  • Assessed current packaging technology and recommended Zone IV packaging options for a commercial product
  • Assisted with shipping studies for a temperature sensitive product, and oversaw CRO performing studies

Quality Systems

  • Reviewed gaps and assisted in rectification of a quality system for an international pharmaceutical company 

Regulatory and Compliance

  • Reviewed a client’s NDA filing for regulatory risk and assisted client in rectifying issues using a priority based tracked
  • Assisted in remediation of CMO investigation into recurring failures for a release method
  • Advised on Drug Master File strategy for a novel drug substance and drug product
  • Acted as a Registered Agent with FDA for a foreign firm


  • Authored an SOP for assessing risk factors to assist in decision making on whether a biological NME (new molecular entity) can be introduced into a facility


  • Wrote stability reports for multiple protocols and studies for a small molecule NME (new molecular entity)
  • Assessed stability data, including use of pooling criteria, to evaluate label claims and comparability of products across different processes and sites
  • Performed our Stabilityshire™ service to evaluate shelf-life recommendations using a validated statistical tool, and made recommendations based on an FDA viewpoint
  • Wrote stability reports on stability performance and trends for an orphan drug

Supplier/Supply Chain

  • Developed cold train strategy, developed study protocols, and assisted with cold chain qualification, and implementation and monitoring
  • Assessed manufacturing and supply chain for a portfolio of vaccines for a major industry investor
  • Performed mock-PAIs for a client’s critical supplier
  • Set-up supply chain management tools, and helped manage product launch for a NME into U.S. and E.U. markets
  • Provided technical assistance to a client visiting their API supplier to assess process changes and the associated impact on the DMF, product quality and the client’s regulatory approach
  • Audited potential third-party logistic (3PL) suppliers and made recommendations
  • Identified and recommended a clinical supply chain management software solution to best meet client needs


  • Provided training to operators, technicians, and quality personnel on environmental monitoring and best practices.

Contact us to explore how we can help your organization succeed– (+1) 844.686.5750 or

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