Regulatory Archives

Case Study

Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey

This case study explores how one biopharma gets deeper insights & more informed decision making…

CertaraMay 13, 2024

Blog

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…

CertaraMay 10, 2024

Blog

Why Medical/Regulatory Writing Services Use Style Guides & Lexicons

Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content…

CertaraMarch 18, 2024

Blog

Best Practices for a Successful eCTD Submission

Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…

CertaraMarch 5, 2024

Conference

DIA MASC

CertaraFebruary 2, 2024

Blog

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…

CertaraDecember 12, 2023

Blog

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

In this blog post, we explore the top 10 things you need to know about…

CertaraOctober 17, 2023

Blog

Maximizing Reusability for Drug Submissions to Different Health Authorities

Many drug developers have products that they want to submit for marketing approval in several…

CertaraSeptember 21, 2023

Case Study

Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program

Certara's support, from dose optimization to medical writing, helps pharmaceutical companies advance their research, make…

CertaraJune 1, 2023

Case Study

Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial

Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…

CertaraApril 17, 2023

Regulatory

Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

Why Medical/Regulatory Writing Services Use Style Guides & Lexicons

Best Practices for a Successful eCTD Submission

DIA MASC

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

Maximizing Reusability for Drug Submissions to Different Health Authorities

Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program

Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial

Newsletter sign up

Quick links

Solutions

Contact