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PSC BIOTECH

PSC is exponentially growing and we are seeking reputable partners to advance with. With PSC’s leading technology, top-tier consultants, and equipment offerings, we offer a unique, one-stop solution for the life sciences.

When working with PSC Biotech®, you can expect a seamless, FDA and EMA compliant, customized solution to all your computer systems validation needs.

Trade Organizations

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Incubators

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Universities

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Calibration Companies

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Venture Capital Firms

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Construction Firms

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Equipment

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Life Science Marketing

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Others

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WE ACCELERATE TOGETHER WITH OUR

Snapshot of Partners

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PSC BIOTECH

PSC Biotech Industry Expertise

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Cosmetics, Cannabis

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Pharmaceuticals Personalized Medicine

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Medical Devices, Biotechnology

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Tissue Products, Cell and Gene Therapy

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Food & Beverages, Homeopathic, Nutraceuticals

Our goals are to provide tailored professional services, act as a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and in full compliance. PSC Biotech® Computerized Systems Validation consultants work to your project needs.

 

To start the process of gaining a PSC Biotech® CSV consultant to design, validate, implement, optimize, review, investigate, audit, or otherwise assist in CSV, contact us today! See our  success pages for  examples of our CSV projects with life science companies.

PSC BIOTECH

The PSC Biotech® Approach to Project Management

Our approach to Project Management is all-encompassing – Project Management Consultants at PSC Biotech assist you in high-level and very detailed aspects of your process and project lifecycle, as the job requires. Our highly trained Project Management Consultants start out doing fieldwork as engineers or technical professionals before undergoing rigorous training. Therefore, they know practical and proficient solutions for your needs. Specifically tailored to your project, our Project Management Consultants achieve success by applying Project Management Institute’s (PMI) Best Practices, The Project Management Body of Knowledge (PMBOK), and ISPE’s Good Practice Guide: Project Management for Pharmaceutical Industry. We employ an integrated Project Management approach to combine practical fieldwork knowledge with project management experience. In this way, the Project Management Consultant is typically responsible for the direct delivery of project success and is engaged with the project, at all levels, throughout the project lifecycle.

 

PSC Biotech® developed specialized project trackers to collect and communicate project status on a real-time basis. Through these trackers, our Project Management Consultants expedite inter-and intra-departmental project facilitation. Also, our project reports are specialized for various project stakeholders, including senior management, project team, contractors, and vendors.

PSC BIOTECH

Extensive Project Management Services

PSC Biotech® also provides project management support for addressing scope creep, engineering, engineering drawings, engineering SOPs, redline pipeline and instrumentation diagrams, preventative maintenance, and product specifications. Furthermore, our Project Management Consultants provide certification programs for capital projects and lifecycle management for process, facility, and utility systems. See our project success pages for examples.

 

PSC Biotech® Project Management Consultants tailor their expertise to your needs. Contact us to start the process of gaining a PSC Biotech® Project Management Consultant to create, optimize, or otherwise meet your project requirements!

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WHITEPAPER

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    YOUR FEEDBACKS

    What Our Clients are Saying

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    Steve Lawson

    Senior Quality Assurance Engineer Biomedical Manufacturer

    "A successful regulatory audit demands meticulous planning, defined roles, and effective communication. AuditUtopia® stands out as the most effective software tool for optimizing communication channels, enabling timely responses and evidence provision. It empowers the right resources within the organization to address auditor inquiries efficiently. With AuditUtopia®, l've navigated multiple intense audits with confidence and wouldn't be without it."

    5.0

    Chris Brady

    Manager, Facilities Engineering Illumina

    "I am very happy with the services that PSC™ has provided. They have helped me here in San Diego and at our Madison site for many years now. They have provided highly-skilled validation specialists that have complemented our full time work force."

    5.0

    Jeff Yuen, MPH, MBA

    Former Commander Food and Drug Administration

    "Seasoned individuals are crucial for successful FDA inspections, managing various tasks seamlessly. AuditUtopia™ has proven its value in streamlining the inspection process, tested in simulated FDA mock inspections. As a former FDA investigator, I wholeheartedly endorse AuditUtopia® for regulated industries. Its efficiency will impress any FDA investigator, ensuring smooth inspection management—an essential bottom line."

    5.0

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