Services / Solutions

The Windward Company provides a broad range of GLP auditing and consulting services.  We are able to draw on our experience to understand and assess your needs to provide you the services that best fit your circumstance.

 

Pre-study placement GLP facility inspections

• Prior to contracting or initiating a GLP study, ensure the facility has the framework in place to conduct GLP studies

Study audits – protocol reviews, In-process inspections and data/report audits

• Review study protocols to ensure the GLP requirements are met
• Confirm study conduct meets applicable GLP and study requirements
• Verify that study reports accurately reflect the data and study conduct and contain the GLP required elements

Quality Assurance Unit (QAU) support

• Auditing assistance and support for your QAU for a short term or periodically on an as needed basis
• Provide QAU services for facilities that do not have the need for full-time QAU personnel
• Provide QAU support for industry task force groups

GLP gap analysis

• Independently assess the GLP compliance of new and existing facilities and provide recommendations for enhancement

Assist with GLP regulatory inspections

• Experienced with hosting FDA and EPA GLP inspections
• Provide advice on preparation, conduct and responding to agency inspections.

GLP program implementation

• Identify the steps needed to achieve GLP compliance
• Assist with Standard Operating Procedure (SOP) development