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.
Advanced Instruments, Inc.
We believe that quality and productivity go hand-in-hand and have built a family of products and services to help biologics manufacturers and process developers ensure the yield, purity, and consistency of biopharmaceutical products through osmolality testing. Whether you need to maintain optimal cell growth, ensure active pharmaceutical ingredient (API) purity and yield, or confirm quality during fill and finishing while helping you remain in compliance with regulations.
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Applied Biosystems by Thermo Fisher Scientific, qPCR
For reproducible results, choose reliable qPCR reagents. Optimized real-time PCR (qPCR) analysis enables sensitive and specific quantification of nucleic acids. Reagent selection plays a critical role in any qPCR or RT-qPCR protocol to help ensure optimal performance and reliable results. Set your analysis up for success by choosing an Applied Biosystems real-time PCR master mix or reagent.
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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CAI
CAI exists to help our customers design, deliver, operate, and maintain quality-critical manufacturing (GMP related) or mission-critical facilities. Our engineering, technical, and consulting services encompass all aspects of operation: equipment, automation, process, and human performance. The result is a superior level of operational performance and reliability.
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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.
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
Founded in 1997, Novotech is a global full-service clinical CRO focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase. Novotech offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with 5,000+ clinical projects. The company has 34 office locations and a team of 3,000+ professionals worldwide.
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Parexel
Parexel is among the world's largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. At Parexel, we design solutions With Heart™️. That means we bring an unparalleled passion, unrelenting commitment to problem-solving, and an empathetic focus on the patient experience to expertly propel clinical trials forward.
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Polyplus
Polyplus SA is the leading biotechnology company that supports Gene and Cell therapy, biologics manufacturing and life science research with innovative nucleic acid transfection solutions. Polyplus strengths are 20 years of experience in manufacturing transfection solutions with tailored scientific and regulatory support to accelerate research. Based in the Science Park close to Strasbourg (France), Polyplus offers an extensive and growing range of transfection reagents available worldwide.
ProPharma
As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate their partners' most high-profile drug and device programs.
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Veristat, Inc.
Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years' experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last 10 years alone.
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Worldwide Clinical Trials
At Worldwide, we understand that each customer and project is unique, so we take a collaborative and personalized approach to identify and meet specific needs and goals. Anchored in our company's scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We apply this deep therapeutic knowledge to develop flexible plans and quickly solve problems in the rapidly evolving clinical landscape.
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