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…
Certara2023 年 10 月 17 日
Maximizing Reusability for Drug Submissions to Different Health Authorities
Many drug developers have products that they want to submit for marketing approval in several…
Certara2023 年 9 月 21 日
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…
Certara2023 年 6 月 1 日
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…
Certara2023 年 4 月 17 日
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…
Certara2022 年 11 月 22 日
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)…
Certara2022 年 10 月 4 日
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…
Certara2022 年 9 月 27 日
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…
Certara2022 年 8 月 25 日
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…
Certara2022 年 6 月 3 日
New PMDA Validation Rules 3.0 Explained
In this blog, we explore what you need to know about the update to the…
Certara2022 年 3 月 2 日
