Katie Winder’s passion for life sciences has always been rooted in a desire to help people. Drawn to the pharmaceutical industry, she sees limitless opportunities to improve health and make a meaningful impact. As a woman in biopharma, Katie values the progress made by those who came before her and embraces her role as a leader. At Syner-G BioPharma Group, she thrives in a team that values respect, support, and knowledge-sharing—an environment that pushes her to be better every day. Learn more about Katie’s journey: https://bit.ly/4hXFrjv #MovingForwardTogether #AccelerateAction #WomensHistoryMonth
Syner-G BioPharma Group
制药业
Framingham,MA 8,752 位关注者
To enable our clients to achieve success and enhance human health while inspiring our colleagues to excel! #weinspire
关于我们
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. Our regulatory affairs services include the development and implementation of global regulatory strategic plans, regulatory agency meeting support, and electronic submissions to regulatory authorities around the world. We have the skill set and experience to guide your prime asset through any development challenges and along the ever-changing maze of regulatory filing pathways, to a position of full compliance, and high quality. Our expertise spans small molecules, peptides, oligonucleotides, biologics, monoclonal antibodies, antibody-drug conjugates, and cell and gene therapy products.
- 网站
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https://www.synergbiopharma.com/
Syner-G BioPharma Group的外部链接
- 所属行业
- 制药业
- 规模
- 201-500 人
- 总部
- Framingham,MA
- 类型
- 私人持股
- 领域
- cGMP Solutions、Regulatory Science for Pharm Development、CMC Formulation Development、Post-Approval CMC、Medical Writing Services、Biologics、Cell and Gene、Project Management、Regulatory Services和CMC
地点
Syner-G BioPharma Group员工
动态
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Regulatory success is built on expertise, collaboration, and a strategic approach to medical writing. Syner-G BioPharma Group's latest case study infographic highlights how a long-term partnership with a global biopharmaceutical leader has accelerated marketing submissions across multiple therapeutic areas, driving timely approvals worldwide. Explore the timeline of achievement and see how a medical writing partnership can make all the difference in navigating complex regulatory pathways: https://bit.ly/3FGLAm4 #RegulatoryAffairs #MedicalWriting #Biopharma #DrugDevelopment
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Priya Puthussery Chathoth’s passion for biopharma began with a fascination for how medicine saves lives. She was drawn to the industry’s role in scientific innovation and its impact on global health. As a woman in biopharma, Priya values the progress women have made in the field, especially in addressing health challenges unique to women worldwide. At Syner-G BioPharma Group, she has grown alongside the company and is committed to empowering the next generation of women in the industry. Inspired by a team culture rooted in kindness and collaboration, she remains dedicated to advancing life-saving treatments for patients. Learn more about Priya’s journey: https://bit.ly/3QClGC0 #MovingForwardTogether #AccelerateAction #WomensHistoryMonth
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Julia DiFiore’s passion for science began in high school, leading her to a career in biopharma where she plays a role in bringing life-changing therapies to patients. The ability to contribute to groundbreaking advancements is what makes her work so rewarding. As a woman in biopharma, Julia recognizes the progress made by those who paved the way for greater inclusion in STEM. She’s proud to be part of a generation pushing for even more equity and innovation. At Syner-G BioPharma Group, she thrives in a culture that values collaboration, flexibility, and continuous learning—where mentorship and teamwork drive success. Learn more about Julia: https://bit.ly/43mUwXo #MovingForwardTogether #AccelerateAction #WomensHistoryMonth
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Advancing from Phase II to Phase III trials is a critical milestone—but it comes with complex CMC and regulatory challenges. A clinical-stage biotech company partnered with Syner-G BioPharma Group to navigate this transition for their anti-interleukin-6 monoclonal antibody therapeutic. With our integrated CMC 360 and Regulatory Affairs expertise, we streamlined manufacturing scale-up, ensured regulatory alignment, and helped drive their drug candidate into multi-national clinical trials. Read the latest Innovations in Biopharma to see how expert partnerships accelerate drug development. #Biopharma #DrugDevelopment #ClinicalTrials #CMC #RegulatoryAffairs
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A well-optimized clinical supply chain is critical to the success of clinical trials. From ensuring investigational products reach sites on time to mitigating risks and maintaining compliance, effective supply chain management plays a pivotal role in trial execution. Syner-G BioPharma Group’s latest white paper explores key components of supply chain strategy, best practices for resource optimization, and approaches to navigating regulatory challenges. Download the white paper to gain expert insights on how to streamline your clinical supply operations and enhance trial efficiency: https://bit.ly/41zVuwV #ClinicalTrials #ClinicalSupplyChain #Biopharma #RegulatoryCompliance
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Marie Monaghan’s curiosity for life sciences began in high school, sparking a lifelong passion for developing treatments that improve lives. As a woman in biopharma, she believes that empathy, collaboration, and diverse leadership drive real innovation in the industry. For Marie, the best part of working at Syner-G BioPharma Group and Sequoia Biotech Consulting is the camaraderie—being surrounded by a team of compassionate and brilliant professionals. Inspired by her mother’s unwavering work ethic, she’s committed to making an impact every day. Learn more about Marie’s journey: https://bit.ly/3QFYTVY #MovingForwardTogether #AccelerateAction #WomensHistoryMonth
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Meet Sujata Kulkarni, Manager of Regulatory Affairs (CMC) at Syner-G BioPharma Group. Sujata’s passion for biotechnology and commitment to advancing healthcare have shaped her career in biopharma. As a woman in the industry, she takes pride in contributing to global health and being part of a growing community of women breaking barriers. She values Syner-G’s supportive culture, where flexibility and recognition fuel both personal and professional growth. Inspired by resilience, determination, and small acts of kindness, Sujata believes even the smallest contributions can create meaningful change. Read more about Sujata’s journey: https://bit.ly/3Xm42WS #WomensHistoryMonth #WomenInSTEM #AccelerateAction #MovingForwardTogether
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Big news at Syner-G BioPharma Group & Sequoia Biotech Consulting! We’re thrilled to welcome Christopher Erickson as our new Chief Operating Officer. With over 25 years of experience in pharmaceutical services, Chris has a proven track record of scaling global operations, enhancing commercial strategies, and driving customer-centric growth. Most recently, Chris was the Chief Commercial Officer at Cytel, where he led exponential growth in operations, consulting, and software. His leadership will be instrumental as we continue to expand and strengthen our integrated life sciences services. Welcome to the team, Chris! Full release: https://bit.ly/4iqHzQv #LifeSciences #Leadership #Biotech #Pharma
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This Women's History Month, we're spotlighting the talented women at Syner-G BioPharma Group and Sequoia Biotech Consulting who are shaping the future of biopharma. From regulatory strategy to product development, their expertise and dedication drive innovation and improve patient outcomes. Throughout March, we’ll be sharing their stories, insights, and the impact they’re making in the industry. Stay tuned as we recognize and celebrate the women who inspire us every day. #WomensHistoryMonth #WomenInBiopharma #WomenInSTEM #OneTeam #WeInspire
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