Regulatory Archives

Case Study

Delivering High-Quality, Timely Responses to EMA Safety Queries

A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines…

CertaraDecember 12, 2024

Case Study

CMC Writing Support Helps Client Lift Clinical Hold

In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the…

CertaraDecember 10, 2024

Blog

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

Blog

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

Blog

Why cancer drug programs need human mass balance studies

Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…

CertaraSeptember 23, 2024

Blog

Resmetirom: A pioneering NASH clinical program

Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…

CertaraAugust 23, 2024

Blog

Subject Exposure in Aggregate Safety Reports & Common Issues

All new and existing drugs should be safe, effective, and efficacious for the treated populations.…

CertaraAugust 16, 2024

Fact Sheet

AI-Enabled Regulatory Writing

CertaraAugust 7, 2024

Blog

How does a clinical development plan help drug programs?

How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…

CertaraJuly 26, 2024

Regulatory

Delivering High-Quality, Timely Responses to EMA Safety Queries

CMC Writing Support Helps Client Lift Clinical Hold

A Medical Writer’s Guide to Collaborative Authoring

How To Respond to Health Authority Questions

Why You Need an Integrated Development Plan

Why cancer drug programs need human mass balance studies

Resmetirom: A pioneering NASH clinical program

Subject Exposure in Aggregate Safety Reports & Common Issues

AI-Enabled Regulatory Writing

How does a clinical development plan help drug programs?

Newsletter sign up

Quick links

Solutions

Contact