Blog Post Quality + Compliance Life Sciences Considerations for Selecting an eQMS Selecting an Electronic Quality Management System (eQMS) is one of the most important technology decisions a life sciences organization can ...
Case Study Pharma People + Change Multi-facility Business Process Mapping Design and Execution for a Pharmaceutical Company Clarkston Consulting recently partnered with a pharma client on a multi-facility business process mapping. Read a synopsis of the project ...
Blog Post Consumer Products Quality + Compliance Enhancing Quality Operations in Consumer Products: A Strategic Imperative Amid today’s supply chain uncertainty and volatile geopolitical landscape, companies are having to be increasingly selective about where they focus ...
Multimedia Life Sciences Medical Device 2025 Medical Device Industry Trends Read our updated trends report here: 2026 Medical Device Industry Trends Clarkston’s team of life sciences consultants have highlighted the ...
Blog Post Life Sciences Medical Device Understanding Recent FDA Guidance on Firm to HCP Communications: Questions & Answers On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...
Blog Post Quality + Compliance Medical Device What You Need to Know About Recent FDA Guidance on Firm-to-HCP Communications Regarding SIUU On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...
Blog Post Quality + Compliance Medical Device PCCP for AI: The FDA’s Latest Guidance on AI in Medical Devices On December 4, 2024, the Food and Drug Administration (FDA) announced a final guidance entitled “Marketing Submission Recommendations for a ...
Blog Post Life Sciences Quality + Compliance Inspection Readiness Team Roles and Responsibilities It’s critical for pharmaceutical, medical device, and biotech companies to always be ready for an announced or unannounced inspection by ...
Blog Post Life Sciences Quality + Compliance What You Need to Know About FDA Remote Regulatory Assessments The Remote Regulatory Assessment (RRA) was originally introduced in an April 2021 Guidance for Industry as a Remote Interactive Evaluation ...
Multimedia Quality + Compliance Life Sciences Five Steps for Process Mapping in Quality It’s critical to have a good understanding of the processes used within your company, but how do we best document ...
Blog Post Consulting Services Quality + Compliance What Your Company Needs to Know About Preparing for an FDA Inspection The FDA has recently updated two compliance program guides addressing PAI inspections (7346.832) and routine GMP surveillance inspections (7356.002). This ...
Blog Post Quality + Compliance Life Sciences What You Need to Know About a QMS Audit The benefits to having a Quality Management System (QMS) are generally well known and understood. Having a quality framework throughout ...
