Case Studies

PMA Case Study

Clinical Investigational Reports for Medical Devices: Supporting Compliance with a Cross-Functional Team

EU IVDR Case Study

Mid-Size Genetic Testing Firm seeking support implementing the new EU IVDR standards

Regulatory Operations Case Study

RegOps Submission Project Management: Things aren't always what they seem

CMC Case Study
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Navigating the Complexities of a Microbiome Product Filing

EU MDR Case Study

Periodic Safety Update Report (PSUR) Vigilance Data Reporting

Regulatory Operations Case Study

Sequence/Serial Numbering for an Initial IND

CMC Case Study
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Consulting and Authoring an Investigational New Drug Application

EU MDR Case Study

Full-Service EU MDR Regulatory Writing, Consulting, Project Management, and Training for a Sustainable Future
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Medical Writing Case Study

Partnering for Efficient Medical Writing Solutions


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EU MDR Case Study

Full-Service EU MDR Deliverable Update with Consulting and Project Management for a Small Start-Up with New Device Technology

EU MDR Case Study

Long-Term Partnership with Large Multinational Corporation for EU MDR Remediation of an Entire Portfolio