Discover Shuai Fu’s project story! Learn how she has overcome the tight schedule for customers' drug submissions and query responses. Certara’s Drug Development Solutions team is ready to help you overcome challenges with the power of biosimulation and regulatory expertise. Connect with our experts today and set your project up for success: https://ow.ly/zPjf50Uu8xh #MIDD #Biosimulation
Certara’s Post
More Relevant Posts
-
Top Blogs of 2024: #1 "Understanding the Process of Drug Development CMC" This year’s most-read blog offers a masterclass in the complexities of CMC and drug development. It’s a must-read for anyone in the industry! Read the #1 blog of 2024 here: https://bit.ly/4gXawD1 Thank you for joining us on this countdown journey! What was your favorite blog this year? Let us know in the comments! #DrugDevelopment #CMC #TopBlogs2024
-
-
Explore the finalized ICH M12 Guideline: Harmonizing global drug-drug interaction standards. Dive into key updates from the draft, compare regulatory perspectives, and offer strategic insights for drug development under the new guidance. 🔗 https://loom.ly/XJ72Irg
-
-
Senior Director, Strategic Product Development Solutions, EU & US, PharmaLex
Willkommen to Berlin! Welcome to Berlin! Today I am speaking at one of the pre-conference workshops about the "importance of a regulatory strategy in global drug development" and "how to navigate within the regulatory landscape in global drug development" at the #RAPSEuroConvergence conference. Please do not hesitate to come and discuss with me, as a member of the #CencoraPharmaLex Development Consulting team. Looking forward to exchanging with you in the coming days! #Regulatory #Strategy #Drugdevelopment #CencoraPharmaLex
-
-
Good overview of 2023 new drug approvals and released guidances.
FDA’s Office of New Drugs (OND) issued their 2023 Annual Report highlighting OND’s successful year for novel drug approvals and other drug development activities that help advance the health of the American public: https://lnkd.in/e7udSaNW
-
Join our webinar this week as we unravel the intricacies of leveraging FDA interactions to drive your projects forward. 📑 💡Key Insights: • Understand the distinct features of INTERACT, pre-IND, and Type D meetings and their unique requirements. • Discover when and how to prepare comprehensively for successful interactions with the FDA. • Acquire knowledge on engaging with the FDA to optimize decision-making processes in early drug development. 🔗 Register now to secure your spot: https://lnkd.in/dR5wMDCy Don't miss out on this opportunity to elevate your understanding of FDA interactions! #TrialWithoutBorders #HiRO #FDA #PreIND #RegulatoryWebinar
-
Take a look at the remarkable achievements of the Office of New Drugs (OND) for 2023! This annual report from the OND details groundbreaking drug approvals for rare diseases to diverse efforts in managing chronic disorders and combating infectious diseases! See the full report below. #OfficeOfNewDrugs | #PublicHealth |#HealthcareInnovation |#RegulatoryScience | #DrugDevelopment | #PatientCare | #FDAApprovals
FDA’s Office of New Drugs (OND) issued their 2023 Annual Report highlighting OND’s successful year for novel drug approvals and other drug development activities that help advance the health of the American public: https://lnkd.in/e7udSaNW
-
Linkedin Top Voice| Life Science Lawyer | Emily Whitehead Foundation Board Member | Entrepreneur | Drexel Univ. Adjunct Prof. | DarshanTalks podcast host | Author, and Speaker
Will Pharma Survive This Shakeup? Trump’s bold appointments, including Elon Musk and RFK Jr., are rewriting the playbook for clinical trials and drug marketing. What does this mean for the industry? Click below to find out. #trumpadministration #healthcarereform #pharmainnovation #kulkarnilawfirm #klf
Ready for Pharma Chaos? Musk, RFK Jr., and other controversial picks are shaking up the life sciences industry. Are clinical trials and drug advertising about to face major changes? Link in comments. #trumpteam #lifesciences #clinicalresearch #drugadvertising #kulkarnilawfirm #klf
-
Relying on existing data, the 505(b)(2) pathway can streamline the drug approval process, bringing modified versions of existing drugs to market faster and at a lower cost. Is it right for you? Find out: https://bit.ly/3z2jSdB #FDAApprovals #DrugDevelopment #ClinicalTrials
-
