Quality is an essential part of the life science product development process. Companies need to ensure that their products are safe and compliant with all quality standards and regulations set by local and/or international bodies. We have extensive hands-on experience in ensuring cGXP, ISO, and CLIA/CAP compliance within the biologics and pharmaceutical industries, including specific expertise that spans small molecules, vaccines, and cell and gene therapies, among other areas.
We provide a wide range of services, including Quality Systems development and implementation, Quality Operations oversight, inspection management, PAI and audit readiness, development of KQIs, and Continuous Quality Improvement methodologies. In addition, we have experience working with various Boards of Health.
As highly focused Global Quality professionals, we are committed to working with your team to create and maintain the highest possible quality standards. Our Quality team possesses a wealth of technical expertise consistent with global regulations and industry expectations.
Our Quality Services include:
- Creating and managing governing documents, including quality plans, policies, and procedures
- Developing systems for document management, leveraging off-the-shelf resources, such as SharePoint, in early stages of the product lifecycle and evolving to apply customized solutions or more comprehensive document management tools
- Remaining current on advances in the industry and providing solutions or more comprehensive document management tools
- Delivering audit-ready systems that can support products in a wide range of developmental states, while being scalable with growth
- Performing GMP, GLP and GCP compliance audits, Gap assessments, PAI readiness, and commercial readiness activities
For more information about how we can support your Quality requirements, please set up a meeting with Dawn Speidel.