Regulatory Sourcing Center
Regulatory challenges facing cell and gene therapy companies are both numerous and complex at every stage of the life cycle.
One look at the U.S. Food & Drug Administration website illustrates that the pathway to cell and gene therapy-related research and development is riddled with regulatory oversight. Understanding and implementing the proactive scientific and regulatory advice to medical researchers and manufacturers in novel product development is arguably the most important aspect of advanced therapies.
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Looking for help understanding Cell & Gene therapy regulations? If you're searching for information or a supplier, let Life Science Connect lend you a hand.
Applied Biosystems by Thermo Fisher Scientific, qPCR
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Avance Clinical
Avance Clinical is a full-service CRO with over three decades of experience, offering high-quality clinical research services across Australia, New Zealand, Asia, North America, and Europe. We specialize in guiding biotechs from pre-clinical development to late-phase studies, with our ClinicReady team for early phases and GlobalReady team for Phase II to III, ensuring expert support at every stage.
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Cencora
Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. We are united in our responsibility to create healthier futures.
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Cytiva
With a rich heritage dating back hundreds of years, Cytiva brings a wealth of technical expertise and talent, a broad and deep portfolio, and exceptional service help researchers and biopharma advance therapeutics at every stage from discovery to delivery. We supply the tools and support our customers need to work better, faster, and safer, leading to the delivery of transformative medicines to patients.
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Danaher Life Sciences
Every day, scientists around the world are dedicated to unraveling the mysteries of disease, discovering novel therapies and vaccines, and conducting crucial drug testing. Danaher Life Sciences comprehensive capabilities go beyond research, enabling us to drive the development of innovative biopharmaceuticals, revolutionary cell and gene therapies, and other breakthrough treatments.
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Germfree
Germfree manufactures a comprehensive line of barrier systems for aseptic control and containment as well as a complete mobile and modular cGMP facilities. We offer advanced solutions to maintain cGMP processes and production for a wide range of biopharmaceutical applications. We are a single source OEM provider of complete cleanroom and lab facilities, and the corresponding integrated equipment designed an purpose-built by our leading-edge fabrication technology, engineering teams and subject-matter experts.
MasterControl, Inc.
MasterControl Inc. is a leading provider of cloud-based Quality Management System (QMS) and Manufacturing Execution System (MES) for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate, and connect critical processes across the regulated product development life cycle.
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MilliporeSigma
At MilliporeSigma, our mission is to help our customers improve human health and life worldwide. This commitment means providing leading life science products and services in ways that also help improve the communities and environment in which we all live.
Novotech
Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster.
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Veristat, Inc.
Veristat, the Science-First™ full service CRO and consultancy, enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development onto regulatory approval and post-marketing. With our focus on novel drug development and 30 years of experience in clinical trial planning and execution, we deliver bold approaches that make the impossible possible.
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