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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Cell & Gene Regulatory Solution Provider - Advanced Instruments, Inc.
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, we offer an osmometer that will keep your processes productive and on track.

Cell & Gene Regulatory Solution Provider - AES Clean Technology
AES Clean Technology

AES Clean Technology is the only USA based cleanroom company that self-performs design, manufacture, and installation of cGMP modular cleanroom facilities. Working with AES, you can rest assured that your project is built on time and on budget, guaranteed.

Cell & Gene Regulatory Solution Provider - AST – Automated Systems of Tacoma
AST – Automated Systems of Tacoma

AST provides innovative and flexible products that satisfy the most challenging product and regulatory requirements for the Pharmaceutical and Biotechnology industries. AST’s spectrum of products includes semi-automated to completely automated and integrated cGMP manufacturing systems for processing vials, syringes and cartridges.


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Cell & Gene Theraypy Manufacturer - CAI
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.

Cell & Gene Regulatory Solution Provider - Cytiva
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.

Cell & Gene Regulatory Solution Provider - Egnyte
Egnyte

Egnyte for Life Sciences is a unified data collaboration platform to serve those advancing the science of health. The advanced platform supports features designed to maintain regulatory compliance, support secure sharing, and manage data governance. More than 16,000 businesses, and more than 400 life science organizations, trust Egnyte to provide visibility and control into their most valuable asset, their data.


Cell & Gene Regulatory Solution Provider - Invetech
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.

Cell & Gene Regulatory Solution Provider - IPS-Integrated Project Services
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.

Cell & Gene Therapy Manufacturer - MilliporeSigma
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.


Cell & Gene Therapy Manufacturer - Precision ADVANCE
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.

Cell & Gene Therapy Manufacturer- Sartorius
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.

Cell & Gene Therapy Manufacturer - Thermo Scientific Product Inspection
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.


Cell & Gene Regulatory Solution Provider - ThermoFisher
Thermo Fisher Scientific Life Science Solutions

As the world leader in serving science, Thermo Fisher Scientific provides the quality materials, services, and support you need to translate your cell therapy from discovery to clinical research and commercial manufacturing. We’re working alongside the scientific community to accelerate the pace of cell and gene therapy development. Because, like you, we believe in the promise of those therapies to fundamentally transform our approach to health care. And we won’t stop until that’s a reality.