Table of Contents
- The Concept
- Issues in Cell and Gene Therapy Manufacturing
- Innovative Strategies Overview
- PDCA Cycle
- Productivity Tools
- Paperless Validation
- Real-time Monitoring
- Cross-functional Teams
- The Five Pillars
- Strategies for Bringing Innovative Cell and Gene Therapies to Market
- About Us
Download the Innovations in Validation: Advancing Cell and Gene Therapies White Paper today!
PSC® can assist in bringing your new cell or gene therapy to clinic
PSC Software® provides innovative technology options for validation data and team communication for regulatory compliance. PSC Software® provides industry-leading real-time quality management software to ensure regulatory compliance goals are met while reducing business costs. See PSCSoftware.com for more information on our adaptive compliance engine (ACE®) products and inspection management system, AUDITUTOPIA®.
PSC Biotech® consultants act as a seamless extension of your company to assist you in accomplishing the projects required to produce the highest quality products. See Biotech.com for more information about the services that we provide. PSC Biotech® has served life science companies in 52 countries across the globe. Contact us for a free consultation on tailored and cost-efficient project assistance for all your quality, validation, systems, and regulatory needs!
We look forward to hearing about your needs in Cell and Gene Therapies and whether we can be of service. Please get started by emailing us at firstname.lastname@example.org or using our contact form online. We have options for professional services and software across a range of budgets and constraints.
PSC Software Solutions
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
Share, Engage, Stay Current
The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The...
Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification,...
Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management. The Importance of First Impressions on Inspection Day Did...