Blog Archives

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Experts Unravel the Top 5 Myths Related to Bioequivalence

Bioequivalence enables bridging safety and effectiveness of oral pharmaceutical dosage forms using pharmacokinetics. The concepts…

CertaraFebruary 18, 2022

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What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…

CertaraFebruary 2, 2022

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Choosing an eCTD Submissions Vendor: Your Complete Checklist

September 3, 2025 Selecting the right electronic submission vendor for regulatory submissions to health authorities…

CertaraJanuary 28, 2022

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Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development

This blog will reflect on 3 things drug developers should pay attention to regarding safety…

CertaraJanuary 24, 2022

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When Should I Select an eCTD Vendor for My Regulatory Submission?

As your company moves towards the regulatory submission of a marketing application to a health…

CertaraJanuary 10, 2022

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A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

New therapeutics discovery and development for ocular diseases have been traditionally associated with a low…

CertaraDecember 15, 2021

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Industry Metrics for CDISC Controlled Terminology

Sergiy Sirichenko summarizes industry metrics across many studies and sponsors to produce an overall picture…

CertaraNovember 17, 2021

Blog

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…

CertaraNovember 5, 2021

Blog

Accelerating ADCs’ development pipeline using Simcyp PBPK

With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading…

CertaraOctober 15, 2021

Blog

A Day in the Life of a Clinical Pharmacology Consultant

Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike…

CertaraOctober 8, 2021

Blog

Experts Unravel the Top 5 Myths Related to Bioequivalence

What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

Choosing an eCTD Submissions Vendor: Your Complete Checklist

Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development

When Should I Select an eCTD Vendor for My Regulatory Submission?

A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

Industry Metrics for CDISC Controlled Terminology

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

Accelerating ADCs’ development pipeline using Simcyp PBPK

A Day in the Life of a Clinical Pharmacology Consultant

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