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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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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Cytiva
Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients. Visit cytiva.com for more.
Capabilities
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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.
Invetech
Invetech helps cell and gene therapy developers to visualize, strategize and manage the future. With proven processes, expert insights and full-spectrum services, we swiftly accelerate life-changing therapies from clinical to commercial-scale manufacturing. With configurable technology platforms and automated production systems, we enable predictable, reproducible products of the highest quality and efficacy.
IPS-Integrated Project Services
IPS-Integrated Project Services is a global provider of technical consulting, architecture, engineering, project controls, construction management, and CGMP compliance services for technically complex pharmaceutical development and manufacturing facilities worldwide.
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 is internationally recognized as the leading Asia Pacific-centered Biotech CRO with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services, and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US, and Europe.
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Pall Corporation
Pall's leading-edge filtration, single-use systems, separation, purification and analytical technologies, as well as technical services in validation, assays and process optimization applicable to laboratory and pilot-scale development, play an essential role in the industry's ability to manufacture these products. As an established global provider of analytical and purification technologies, Pall supports faster development of new drugs and vaccines around the world.
Polyplus-transfection
Polyplus-transfection® 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-transfection's 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-transfection offers an extensive and growing range of transfection reagents available worldwide.
Precision ADVANCE
Precision ADVANCE is a collection of interconnected services and complementary teams uniquely focus on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market. Learn more about how we accelerate clinical development with Precision for Medicine, optimize next-gen manufacturing with Project Farma and drive commercial success with Precision Value & Health.
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Sartorius
The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions complementary technologies.
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Thermo Scientific - Bioproduction
Thermo Fisher Scientific is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our brands, we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
Veristat
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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Waters Corporation
Waters Corporation unlocks the potential of science through analytical measurement technology, deep scientific expertise, and reliable insights to enhance human health and well-being. As a global leader in analytical instruments, consumables, and software, Waters has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years.
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