FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format Blog FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format March 19, 2025 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…CertaraMarch 19, 2025
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline Blog Rolling NDA and BLA Submissions: Accelerate Your Review Timeline We look at the growing regulatory trend of rolling NDA and BLA submissions to help…CertaraFebruary 3, 2025
GlobalSubmit 4.0 Webinars On-Demand Webinar GlobalSubmit 4.0 Webinars The world of electronic regulatory submissions is about to change with the introduction of eCTD…CertaraDecember 3, 2024
Best Practices for a Successful eCTD Submission 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
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions 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
Maximizing Reusability for Drug Submissions to Different Health Authorities 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
The eCTD Submission Process: Tips and Tricks for Drug Development Success White Paper 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
GlobalSubmit WebReview Key Features On-Demand Webinar GlobalSubmit WebReview Key Features CertaraJune 22, 2020
FDA’s New ANDA Submissions Guidance: Key Points Blog FDA’s New ANDA Submissions Guidance: Key Points The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…CertaraSeptember 27, 2018