MMS

We are proud to share that the regulatory team at MMS has been selected as one of three top finalists in the Fierce CRO Awards for Leadership in Regulatory Compliance! The Leadership in Regulatory Compliance category recognizes CROs that demonstrate exemplary adherence to regulatory standards and guidelines, ensuring compliance and facilitating smooth regulatory submissions. With zero refusals to file since inception, MMS has been instrumental in helping Sponsors successfully bring more than 50 submissions to global health authorities in the last five years, including INDs, NDAs, and BLAs. Read the full press release for details: https://lnkd.in/gYRbRAns #OneMMS #PharmaceuticalIndustry #ClinicalResearch #DrugDevelopment #RegulatoryStrategy #NewDrugApproval CC: Fierce Pharma, Fierce Biotech

New Perspectives: The regulatory knowledge required to support grandfathered OTC drugs down newer regulatory paths is immense. As part of the 2020 CARES Act, the FDA affirmed the GRASE conditions for certain OTC therapeutic drug classes by establishing 32 OTC Monographs. Some OTC drugs and drug classes had not yet met the regulatory burden to receive a deemed final order. Part of a legacy system, they’ve been "grandfathered" into the market until the FDA issues a ‘not GRASE’ final order which would force these drugs off of store shelves. MMS details this, the critical challenges that lie ahead, and the path forward in our latest article: https://hubs.li/Q02ZGWV-0 #OTC #OTCmonograph #GRASE #FDA #Pharma #RegulatoryStrategy #MedicalWriting

We find that exceptional teamwork leads to exceptional outcomes! It sounds simple, but our medical writing team’s collaboration on this CSR reflects the high standards we bring to every project, ensuring quality that Sponsors can trust. The forward-thinking medical and regulatory writers at MMS produce cohesive, scientifically-accurate, and regulatory-robust documents. Learn more here: https://hubs.li/Q02ZkDjL0 #SponsorsSay #ClinicalResearch #CSR

What does it take to design effective clinical trial protocols? We have an answer for you. From minimizing risks to simplifying operations, well-crafted protocols are the foundation of successful clinical trials. Thoughtful design does 3 things well. It: ? ensures regulatory compliance, ? improves patient outcomes, and ? boosts operational efficiency—setting trials up for success from the start. Explore strategies for better trial design and protocol development in our Perspectives blog article: https://hubs.li/Q02Z0lpv0 #ClinicalTrials #ProtocolDevelopment #ClinicalResearch

Meet Sasha Chetal! A remote Project Manager at MMS, hailing from Aberdeen, Scotland. Renowned for her exceptional white glove service, Sasha brings a decade of industry expertise to her role. She skillfully directs and manages the scientific, technical, and operational facets of projects in diverse therapeutic areas, including neuroscience, oncology, infection, respiratory, rare diseases, and inflammation. Sasha holds a Master's in Veterinary Microbiology, leveraging her extensive experience in translational research to consistently "Wow the Customer" - an embodiment of one of our core values at MMS. Discover more about our solutions and feel free to ask for Sasha by name: https://hubs.li/Q02Yvm980 #OneMMS #neuroscience #oncology #rarediseases

We are thrilled to announce that MMS has once again been recognized as a Top Workplaces award winner by the Detroit Free Press and the USA TODAY Network! This honor is especially meaningful because it reflects the voice of our employees. Over the past year, the Top Workplaces survey gathered insights from more than 2 million employees across 8,000+ organizations—and MMS continues to stand out as a place where innovation thrives, collaboration excels, and people are truly valued. To our incredible team: Thank you for bringing your dedication, expertise, and passion to work every day. Celebrate with us in the comments!?For full details on the win, read here: https://lnkd.in/gnzhsC5Z #TopWorkplaces #OneMMS #DrugDevelopment

Strong partnerships start with expertise and teamwork! From day one, MMS has focused on delivering the right support to drive meaningful progress, ensuring every step leads to impactful outcomes. Explore our Biometrics solutions, for instance, where the advantages that MMS brings include better trial data execution, lower risk, stronger submissions, and accelerated outcomes. Let's explore how we can advance your next Biometrics project: https://hubs.li/Q02Yvrk-0 #SponsorsSay #ClinicalResearch #ClinicalData

ICYMI: MMS was recognized with EcoVadis Bronze Medal for leadership in ESG sustainability efforts as a leading CRO! Ben Dudley, MMS Chief Commercial Officer, shared, “MMS is one of the few CROs that has been ISO certified since inception, and our dedication to deep processes, sustainability, and ethical practices remains integral to our approach. From reducing environmental impact in trial designs to fostering a diverse, inclusive, and ethical workforce, we are working to set new standards for what it means to be a responsible CRO partner.” Read more about this award and our commitment to sustainability: https://hubs.li/Q02Ykvb80 #Sustainability #ESG #Leadership #Pharma

Do you need help in turning around distressed studies and getting them back on track? With MMS Transition & Rescue Solutions, our biometrics and regulatory experts take the burden off your shoulders and ensure a smooth, pain-free transition—without significant delays or budgetary concerns. Our keys for a successful rescue include: ?? Transition process management, and a well-established playbook to mitigate any risks for you and ensure smooth continuity. ?? Seamless technology transitions, ensuring that technical challenges are resolved quickly through in-house resource and leading-edge innovations for minimal disruption. ?? Regulatory gap analysis that goes beyond just fixing immediate issues to gain a proactive assessment of your data for regulatory compliance. When quality, compliance, and timelines are at risk, MMS is here to help. Read our latest thoughts on rescue work here: https://hubs.li/Q02YcGYc0 #ClinicalTrials #CRO #ClinicalResearch #DataManagement #Pharma #DrugDevelopment #ClinicalData #OneMMS

Building strong, reliable partnerships is no small feat in clinical research! We like to prioritize responsiveness and high-quality service, working collaboratively with you to ensure that every project is delivered efficiently and with precision. Looking for a partner you can count on? Review our solutions: https://hubs.li/Q02Y2w980 #SponsorsSay #ClinicalOperations #Pharma