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
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
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
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
The eCTD Submission Process: Tips and Tricks for Drug Development Success
Our experts compiled the tips and best practices you need to know for a successful…
CertaraNovember 22, 2022
Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist
Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D)…
CertaraOctober 4, 2022
5 Steps to Satisfy New EU-CTR Requirements for Plain Language Summaries of Clinical Study Results
For the first time, the European Medicines Agency (EMA) has passed new regulations to help…
CertaraSeptember 27, 2022
3 Major Implications of New European Clinical Trial Regulations
Have you heard the buzz around the new European Union Clinical Trial Regulations (EU-CTR) for…
CertaraAugust 25, 2022
Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a…
CertaraJune 3, 2022
New PMDA Validation Rules 3.0 Explained
In this blog, we explore what you need to know about the update to the…
CertaraMarch 2, 2022
