Success Stories

Medical Writing Document Production Case Study

Restoring Compliance in Electronic Document Signing

Medical Writing IMPD Case Study

Developing Efficient Solutions to Client Needs

Medical Writing aCSR Case Study

Managing Complexity: Abbreviated CSR Delivery for a Rare Disease Program

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

A new client requested publishing for an IND with a tight deadline

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
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Regulatory Operations Case Study

Sequence/Serial Numbering for an Initial IND

CMC Case Study

Consulting and Authoring an Investigational New Drug Application
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EU MDR Case Study

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

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
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