Regulatory - Blog Archives

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Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC

Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the…

CertaraFebruary 19, 2025

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Streamline Clinical Data Publication Under EMA Policy 0070

February 14, 2025 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…

CertaraFebruary 14, 2025

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Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

We look at the growing regulatory trend of rolling NDA and BLA submissions to help…

CertaraFebruary 3, 2025

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How to Validate Your Clinical Data Using FDA Validation Rules

January 30, 2025 For clinical data managers, understanding clinical data validation and applying FDA validation…

CertaraJanuary 30, 2025

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Anonymization vs. Redaction of Clinical Trial Data

January 17, 2025 The vernacular for disclosing pharmaceutical clinical trial results to the public may…

CertaraJanuary 17, 2025

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CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know

December 3, 2024 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for…

CertaraDecember 3, 2024

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A Medical Writer’s Guide to Collaborative Authoring

Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…

CertaraNovember 22, 2024

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FAQs on Developing EMA Policy 0070 Submissions

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…

CertaraNovember 1, 2024

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How To Respond to Health Authority Questions

Your biotech company has just submitted the marketing application for your first drug product. It’s…

CertaraOctober 25, 2024

Blog

Why You Need an Integrated Development Plan

Learn about the Integrated Development Plan for successful drug development & its relation to the…

CertaraOctober 17, 2024

Regulatory – Blog

Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC

Streamline Clinical Data Publication Under EMA Policy 0070

Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

How to Validate Your Clinical Data Using FDA Validation Rules

Anonymization vs. Redaction of Clinical Trial Data

CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know

A Medical Writer’s Guide to Collaborative Authoring

FAQs on Developing EMA Policy 0070 Submissions

How To Respond to Health Authority Questions

Why You Need an Integrated Development Plan

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