Syner-G BioPharma Group provides comprehensive services in product development, regulatory strategy and submissions, functional outsourcing, medical writing, and quality and compliance.

Syner-G BioPharma Group

Syner-G BioPharma Group | 7,910 followers on LinkedIn. To enable our clients to achieve success and enhance human health while inspiring our colleagues to excel!  #weinspire | Syner-G BioPharma Group provides in-depth expertise across the three key elements of Chemistry, Manufacturing, and Controls (CMC): Regulatory Services, Technical Development, and Quality/IT. We call this CMC 360™. We also provide medical writing services, with expertise in authoring a variety of regulatory documents across a wide range of therapeutic areas and in all phases of development.

Global Life Sciences Leader | Commercial Executive

Brian Howell

Regulatory professional in the pharmaceutical industry dedicated to bringing new treatment options to market.

Frank Bottone Jr, PhD, RDN

Scott Rudge

Director, IT at Syner~G Biopharma Group

Jac Camp

Honoring all those who have served, Syner-G BioPharma Group extends heartfelt gratitude to our veterans for their dedication, courage, and sacrifice. This Veterans Day, we recognize the invaluable contributions of those who have protected our freedoms and who continue to make an impact within our communities. Thank you for your service. #VeteransDay

Syner-G BioPharma Group is proud to recognize and celebrate our employees who consistently demonstrate our company values through the 2024 Quarter 3 ‘You Inspire Me’ Awards. These individuals were nominated by their peers for their outstanding dedication to supporting our clients and promoting teamwork, while living our values in their day to day work. Congratulations to our award recipients Kasturi Puranam, Bobby Gollmar, L. Alexis Hoeferlin , and Sujata Kulkarni! Your commitment to cultivating a collaborative culture and setting a high standard of excellence within our organization is truly commendable. #WeInspire #OneTeam #MissionandValues

We’re proud to announce that Syner-G BioPharma Group 's employee benefits package has been independently recognized as one of the best in the industry by Mployer . This award reinforces our commitment to supporting the well-being of our team members and their families. At Syner-G, we believe that investing in our people is the foundation of our success. Join us and experience a workplace that values you—both professionally and personally. #TopBenefits #EmployeeSupport #OneTeam #WeInspire

Looking to build a fulfilling career that makes a real impact? Join the Syner-G BioPharma Group team! Discover exciting opportunities on our Career Page and see how you can contribute to advancing life sciences. https://bit.ly/4fl3FCN Our Talent Acquisition team will be at the Hire Life Science Career Fair this Thursday, November 7th. Stop by our booth to explore inspiring roles and connect with us – we’d love to meet you! Be sure to register in advance to secure your spot and get all the event details. https://bit.ly/4hiSv32 #regulatoryaffairs #cmc #biopharma #lifesciences

Elevate your expertise in pharmaceutical manufacturing by attending the Tablets and Capsules Hands-On Short Course at the University of Maryland. Myke Scoggins , Senior Director of CMC Development and Project Management at Syner-G BioPharma Group , will present on "Micromeritics and Bulk Powder Properties," offering key insights into powder behavior, formulation strategies, and quality control. This program combines theory with practical lab sessions, providing a complete understanding of the manufacturing process. Don’t miss this opportunity from November 11-15, 2024. Course information: https://bit.ly/3ZMSKxa #PharmaceuticalScience #CMCDevelopment #PharmaTraining

Navigating the reshoring of operations in the biopharma industry requires a reliable partner. At Syner-G BioPharma Group , we provide expert support in manufacturing and compliance to ensure your supply chain remains secure. Recently, we assisted a virtual U.S. biopharma company in managing two CDMO sites in India, maintaining a compliant drug substance supply for over 20 months. Read our case study to see how we harmonized procedures and enhanced quality culture: https://bit.ly/4fgtyUe Ready to elevate your operations? Let’s connect for a brief meeting to discuss how we can support your evolving needs. https://bit.ly/4hmmmb4 #Biopharma #CDMO #CaseStudy

Our Talent Acquisition team will be in Boston on November 7th at the Hire Life Science Career Fair, actively seeking talented professionals to join our growing team. This is a fantastic opportunity to connect with Syner-G BioPharma Group and other leading life science companies as you explore your next career move. Register now to secure your spot and learn more about event details! https://bit.ly/4hiSv32 Interested in exploring opportunities with Syner-G? Explore our careers page to view our current openings and see how you can become part of our innovative team. https://bit.ly/4fl3FCN #LifeSciences #TalentAcquisition #CareerFair

As we approach November, it's essential to proactively plan depot transfers and site shipments to ensure seamless patient dosing over the holiday period. Take the time to review your patient forecasts, upcoming maintenance requirements, and product expiry dates to accurately determine the material needed for transfer to depots. Planning for the period from November through the end of January can help mitigate potential disruptions in patient dosing. For sites where patients are scheduled for dosing during the holiday season, consider arranging a manual site shipment ahead of time to confirm that the Investigational Product (IP) is available on site. De-risking the supply chain during the holiday season is a best practice, offering assurance and operational continuity during the busy end-of-year period. Syner-G BioPharma Group is ready to provide comprehensive clinical supply management support for both ongoing and new clinical supply chain needs. Contact us to learn more about how we can assist. https://bit.ly/3Y9zJ5C #ClinicalTrials #SupplyChainManagement

The biopharmaceutical industry is no stranger to economic challenges, but thoughtful strategies can help mitigate risks and ensure continued innovation. In this recent article, Syner-G BioPharma Group CEO Ron Kraus discusses the current economic climate and outlines key approaches for navigating uncertainty. From enhancing team capabilities to balancing immediate and long-term objectives, Ron provides valuable insights for maintaining progress and driving success in drug development. Read the full article to explore these strategies in depth: https://bit.ly/4eTVcGm #Biopharma #StrategicPlanning #LifeSciences

Gene and cell therapies are at the forefront of medical innovation, offering new possibilities for treating complex diseases. However, their success hinges on the robust processes defined by Chemistry, Manufacturing, and Controls (CMC). Our latest piece explores the critical role CMC plays in ensuring these therapies meet the highest standards of safety, quality, and efficacy throughout development, production, and commercialization. Discover how a well-structured CMC strategy is essential to advancing these groundbreaking therapies and meeting regulatory requirements: https://bit.ly/4epeJhP #GeneTherapy #Biopharma #RegulatoryAffairs #CMC

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Syner-G BioPharma Group