Accelerating healthcare and life sciences research, product development, and market growth
MassMEDIC is hosting their next Regulatory Roundup on 13nov. These roundups offer valuable insights and guidance for navigating the FDA as a medtech company. I strongly recommend those planning, or in the middle of, regulatory filings to attend. #fda #medtech #regulatory
In this three-part blog series, Dr Eric Hardter, Ph.D., RAC (US, CAN, EU), Associate Director of Regulatory Affairs at Boyds, provides advice and guidance to sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome. Read part 1 of the series here: https://lnkd.in/deg57-Ym or get in touch with one of our award-winning regulatory experts for personalised support in preparing for your FDA meeting. #FDA #FDAmeeting #regulatoryaffairs
Associate Director, Regulatory Affairs at Boyds | Investigational Product Lifecycle Development | Cell and Gene Therapy | Multidisciplinary Strategy | Team and Project Leadership
In authoring this blog series I’ve leveraged my extensive experience in formal meetings with the US FDA. Such meetings can function as key components of drug lifecycle development risk mitigation, so understanding the “why, when and how” is critical. I hope you enjoy reading, and as always please reach out with any questions!
In this three-part blog series, Dr Eric Hardter, Ph.D., RAC (US, CAN, EU), Associate Director of Regulatory Affairs at Boyds, provides advice and guidance to sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome. Read part 1 of the series here: https://lnkd.in/deg57-Ym or get in touch with one of our award-winning regulatory experts for personalised support in preparing for your FDA meeting. #FDA #FDAmeeting #regulatoryaffairs
MS Regulatory affairs at Northeastern University | Actively seeking Co-op\internship opportunities
🎉 Exciting News! 🎉 I am thrilled to announce that I have successfully completed the RAPS webcast on overcoming friction in FDA submission processes. This experience has been incredibly valuable, providing me with deep insights and practical knowledge to navigate FDA submissions more efficiently. A big thank you to the Regulatory Affairs Professionals Society (RAPS) for organizing this informative session and to all the speakers for their expertise. Looking forward to applying these insights in future projects and continuing my journey in regulatory affairs with even greater proficiency! #FDA #RegulatoryAffairs #ProfessionalDevelopment #RAPS #ContinuousLearning
Managing data standards requirements for regulatory submissions in global trials can be challenging. We share our wealth of regulatory expertise in our on-demand webinar, comparing FDA and PMDA requirements for data standardisation to provide useful, actionable insights to improve your submission package. Watch our webinar now to dive into the details: https://ow.ly/hWTq50R8oCw
Managing data standards requirements for regulatory submissions in global trials can be challenging. In this blog, we share our wealth of regulatory expertise, comparing FDA and PMDA requirements for data standardisation to provide useful, actionable insights to improve your submission package. https://ow.ly/Blfe50ScOwA
In the final installment of this three-part blog series, Dr Eric Hardter, Ph.D., RAC (US, CAN, EU), Associate Director of Regulatory Affairs at Boyds, provides advice and guidance for sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome. Read the blog here: https://lnkd.in/eFyjYP6M #FDA #RegulatoryAffairs #preIND
Associate Director, Regulatory Affairs at Boyds | Investigational Product Lifecycle Development | Cell and Gene Therapy | Multidisciplinary Strategy | Team and Project Leadership
I’ve concluded my mini-series on formal FDA meeting best practices with this blog post. Read on to see how best to approach the meeting itself!
In the final installment of this three-part blog series, Dr Eric Hardter, Ph.D., RAC (US, CAN, EU), Associate Director of Regulatory Affairs at Boyds, provides advice and guidance for sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome. Read the blog here: https://lnkd.in/eFyjYP6M #FDA #RegulatoryAffairs #preIND
Turn your pre-IND meeting into a strategic advantage and set the stage for a smooth regulatory journey. Here are essential tips on key discussion points, effective communication strategies, and aligning your development plan with FDA expectations: https://hubs.ly/Q02Cd_0m0 #clinicaltrials #clinicalresearch #drugdevelopment
In the second installment of this three-part blog series, "Navigating an FDA Meeting – Best Practices for Maximizing Your Time and Effort," Eric Hardter, Ph.D., RAC (US, CAN, EU) provides an in-depth exploration of two crucial aspects: Building your submission documentation and establishing a regulatory timeline. Read the blog here: https://lnkd.in/ejabPg9i or get in touch with one of our award-winning regulatory experts for personalized support in preparing for your FDA meeting, contact info@boydconsultants.com. #FDA #RegulatoryAffairs #preIND
New blog section is available! Link below.
In the second installment of this three-part blog series, "Navigating an FDA Meeting – Best Practices for Maximizing Your Time and Effort," Eric Hardter, Ph.D., RAC (US, CAN, EU) provides an in-depth exploration of two crucial aspects: Building your submission documentation and establishing a regulatory timeline. Read the blog here: https://lnkd.in/ejabPg9i or get in touch with one of our award-winning regulatory experts for personalized support in preparing for your FDA meeting, contact info@boydconsultants.com. #FDA #RegulatoryAffairs #preIND
