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Regulatory blogs

Anonymization vs. Redaction of Clinical Trial Data
Anonymization vs. Redaction of Clinical Trial DataBlog

Anonymization vs. Redaction of Clinical Trial Data

January 17, 2025 The vernacular for disclosing pharmaceutical clinical trial results to the public may seem just as confusing as the process! Some people…
FAQs on Developing EMA Policy 0070 Submissions
FAQs on Developing EMA Policy 0070 SubmissionsBlog

FAQs on Developing EMA Policy 0070 Submissions

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for…
How To Respond to Health Authority Questions  
How To Respond to Health Authority Questions  Blog

How To Respond to Health Authority Questions  

Your biotech company has just submitted the marketing application for your first drug product. It’s a moment of celebration after…
Why You Need an Integrated Development Plan
Why You Need an Integrated Development PlanBlog

Why You Need an Integrated Development Plan

For a small biotech company developing its first drug asset, the path is fraught with challenges. The complexity of drug…

Popular Resources

How to Make 3rd Party Reconciliation in Clinical Data Management More Efficient
How to Make 3rd Party Reconciliation in Clinical Data Management More EfficientBlog

How to Make 3rd Party Reconciliation in Clinical Data Management More Efficient

MIDD’s Growing Role in Global Health: A Case Study of Primaquine Exposures in Lactating Women and Breastfed Infants
MIDD’s Growing Role in Global Health: A Case Study of Primaquine Exposures in Lactating Women and Breastfed InfantsWebinar

MIDD’s Growing Role in Global Health: A Case Study of Primaquine Exposures in Lactating Women and Breastfed Infants

How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?
How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?Article

How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?

Blending Science & Impact in Drug Development: Felix Boakye-Agyeman, Vice President of the QSS Division at Certara
Blending Science & Impact in Drug Development: Felix Boakye-Agyeman, Vice President of the QSS Division at CertaraVideo

Blending Science & Impact in Drug Development: Felix Boakye-Agyeman, Vice President of the QSS Division at Certara

Behind the Science: Meet Project Manager Chantal Morin
Behind the Science: Meet Project Manager Chantal MorinVideo

Behind the Science: Meet Project Manager Chantal Morin

Bridging Strategy & Execution: Sophia Fong’s Approach to Drug Development
Bridging Strategy & Execution: Sophia Fong’s Approach to Drug DevelopmentVideo

Bridging Strategy & Execution: Sophia Fong’s Approach to Drug Development

All Regulatory resources

eCTD 4.0: When & Where it will be Implemented Next

Certara Products - GlobalSubmit, Webinar - Resources LP - Upcoming, Webinar

Write Quicker PBPK Reports with the Simcyp Report Assistant

Certara Products - Simcyp, Modeling and Simulation - PBPK, Blog

Delivering DSUR Excellence for Multinational Biopharma

Certara Services, Case Study

Model-Based Meta-Analysis (MBMA) for Relative Treatment Effects and Absolute Outcomes: A Focus on Concepts and Applications 

Model-Based Meta-Analysis (MBMA), Webinar - Resources LP - Upcoming, Webinar

Revolutionizing Medical Writing: AI Accelerates Drug Development Efficiency [Chinese webinar]

Certara Products, Webinar

How Certara MIDD Experts Overcame Client Regulatory Challenges

Homepage Latest, Case Study

Standardizing Real World Data in Rare Disease: ATHN’s Journey

Certara Products - Pinnacle 21, Certara Services, Homepage Latest, Case Study

What’s New in Phoenix 8.6?

Webinar

Unlocking Success with Phoenix Hosted: Real-World Customer Stories

Certara Products - Phoenix, Case Study

How to Make 3rd Party Reconciliation in Clinical Data Management More Efficient

Certara Products - Pinnacle 21, Clinical Data Validation, Blog

MIDD’s Growing Role in Global Health: A Case Study of Primaquine Exposures in Lactating Women and Breastfed Infants

Modeling and Simulation - PBPK, Webinar - Resources LP - Upcoming, Webinar

How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?

Article
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