Suttons Creek

Today, four leading life science companies—Suttons Creek, Modality Solutions, Clintrex, and ToxStrategies, a BlueRidge Life Sciences Company—announce their unification under a new brand:?BlueRidge Life Sciences. BlueRidge Life Sciences is a growing family of companies that provides a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting. For more information: https://lnkd.in/g6zecez4

We are excited to introduce ?????????????????? ???????? ????????????????, the result of a strategic unification of Suttons Creek, Modality Solutions, CLINTREX Research, and ToxStrategies’ divisions—Center for 21st Century Toxicology, EpidStrategies and HEORStrategies. BlueRidge combines deep scientific expertise with real-world experience to deliver practical, integrated solutions to complex technical and regulatory challenges. Visit our website to learn more: https://lnkd.in/ePjB62_Q #BlueRidgeLifeSciences #LifeSciences #Healthcare

Suttons Creek is heading to SAE Media Group’s Pre-Filled Syringes and Injectable Drug Devices East Coast in Boston April 28th?to 30th, and we would love to see you there. Former FDA Reviewer, now Suttons Creek Senior Principal Consultant, Max Lerman, PhD will be speaking on the 29th?alongside President and Managing Partner, Steven Badelt, PhD. They, along with Konrad Walzer and Alan Humphrey, will also be hosting a Suttons Creek booth at the show to talk through your combination product challenges in search of solutions. Take your next step in capitalizing on this learning opportunity in Boston: More info on the show:?https://lnkd.in/gG9jBA_m Contact us to set a meeting:? email: [email protected] web form: https://lnkd.in/e37qh24v SAE Media Group FDA #FDA #prefilledsyringes #autoinjectors #connecteddevices #connectedhealth #drugdelivery #combinationproducts #medtech #regulatoryaffairs #devicedevelopment

As digital transformation reshapes regulatory compliance, many organizations are turning to advanced Requirements Management Software to streamline the creation and linkage of Design History File (DHF) documentation. HOWEVER, while this automation improves traceability, it can sometimes lead to outputs filled with extensive links that, although technically complete, may not tell a cohesive, digestible story for the reviewer.?To truly benefit from Requirements Management Software,?we have outlined some considerations and guidelines based on hands-on experience with our clients. We will be sharing these insights in an email to our subscribers this Thursday at noon.?To receive it, and more combination product tips like it, click here: https://lnkd.in/gA4ngeWi. #combinationproduct #drugdeliverydevice #pharma #dhf #biotech #medtech #fda #regulatorysubmission #devicedevelopment

For a "cheat sheet" of combination product risk management responsible parties, click here: https://lnkd.in/gzGZai2F #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

As the pharmaceutical and medical device industries innovate, the need for drug delivery system experts grows…and so Suttons Creek continues to expand its talent pool of combination product specialists. We are happy to announce that?Konrad Walzer?is joining the company as our newest Technical Director and?Kenny Lin, who has been working with us as a part-time consultant, is now officially on the team as a full-time Principal Project Manager. For more information about Konrad and Kenny and their roles at Suttons Creek, visit: https://lnkd.in/g3mMqf2F #combinationproduct #drugdelivery #drugdeliverysystem #devicedevelopment #pharma #biotech #medtech Rob Schulz, Mickey Burg

Who does what in a combination product's hazard analysis, risk assessments, and risk control? Click here to find the answers: https://lnkd.in/gkNkkKwR #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

A drug delivery system's risk priority levels will be based on designated definitions of severities of harm and scales of probability of harm. To review the crucial tools our consultants use for assessing risk and assigning risk scores, click here: https://lnkd.in/gn6_45rw #medtech #medicaldevices #combinationproduct #pharma #biotech #drugdelivery #devicedesign #deviceregulatory #devicedevelopment #medicaldevice #riskmanagement

Mark your calendar for a trip to the future...of combination products with James Wabby of AbbVie and Suttons Creek's Courtney Evans. Use the below link to register for their ISPE webinar on April 30th at 10am EST, during which they will discuss the latest regulatory expectations and potential future innovation platforms and global convergence/harmonization initiatives for combination products. https://lnkd.in/gBZqmN9t #combinationproduct #drugdelivery #drugdeliverydevice #medtech #pharma #biotech #regulatoryaffairs #devicedevelopment

Imagine this common scenario...You are a large Pharma company with multiple drug delivery device systems in development. Two autoinjector programs with similar drug risk profiles and identical autoinjector devices are progressing a few months apart…and management realizes each team is using a completely different control strategy. The client asks us, “Is this something we should be concerned about?” Find out our general answer when we are asked this question by signing up for our email list: https://lnkd.in/gA4ngeWi #combinationproduct #drugdelivery #deliverydevice #devicedevelopment #pharma #biotech #medtech #controlstrategy #fda