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ICH Q14- Analytical Procedure Development

ICH Q14- Analytical Procedure Development

Jun 26, 2024 Read more
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ICH Guidelines Decoded

ICH Guidelines Decoded

Jun 7, 2024 Read more
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Transform Your Life Science Projects with PSC at BIO 2024

Transform Your Life Science Projects with PSC at BIO 2024

May 22, 2024 Read more
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Decoding ISO 17025 Accreditation

Decoding ISO 17025 Accreditation

Feb 27, 2024 Read more
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How Can Outsourcing Professional Services Boost Your Company?

How Can Outsourcing Professional Services Boost Your Company?

Feb 13, 2024 Read more
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PSC Biotech CSV Services

PSC Biotech CSV Services

Jan 18, 2024 Read more
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21 CFR Part 11

21 CFR Part 11

Jan 3, 2024 Read more
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Embracing the Era of Digital Transformation

Embracing the Era of Digital Transformation

Dec 10, 2023 Read more
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From Simple to Spectacular: A Beginner’s Guide to Technical Drawings

From Simple to Spectacular: A Beginner’s Guide to Technical Drawings

Nov 10, 2023 Read more
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As-Built Data: A Vital Component of Construction Project Handover

As-Built Data: A Vital Component of Construction Project Handover

Oct 24, 2023 Read more
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Navigating the Regulatory Maze: How PSC Biotech Lights the Way

Navigating the Regulatory Maze: How PSC Biotech Lights the Way

Sep 25, 2023 Read more
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Handling Deviations in a Life Science Environment

Handling Deviations in a Life Science Environment

Aug 23, 2023 Read more
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A Simple and Helpful Guide to Quality Document Review

A Simple and Helpful Guide to Quality Document Review

Jun 13, 2023 Read more
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PSC Biotech and PSC Software: The One-Stop Solution for All Your Life Science Needs

PSC Biotech and PSC Software: The One-Stop Solution for All Your Life Science Needs

Jun 5, 2023 Read more
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Precision: Driving Success in Life Science through Calibration & Metrology

Precision: Driving Success in Life Science through Calibration & Metrology

Apr 26, 2023 Read more
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Regulatory Strategy Development for Life Sciences: Best Practices

Regulatory Strategy Development for Life Sciences: Best Practices

Apr 3, 2023 Read more

What Our Clients are Saying

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®, I’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, MPE, 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

Angele Zaboura

General Manager
Beit Jala Pharmaceutical

“This is to certify that PSC Biotech® (PSC®) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

5.0

Sharon Fisher

Quality Manager
MicroGEM

“During the past year, our company has been working with PSC® on various activities within the development and implementation of a new medical device product. PSC® offers high quality services, and we can say that we have always been satisfied by their work.”

5.0

Emerson Perin, MD, Phd

Quality Manager
MD Texas Heart Institute

“I cannot recommend anyone more highly than I recommend PSC®. They have been a godsend.”

5.0

Tiffanie Browne

Supply Chain Manager
Takeda

“PSC®’s regulatory support was instrumental in overcoming a significant obstacle. Their independent approach, willingness to collaborate cross-functionally, and great communication eliminated the need for micromanagement. With minimal supervision, their expertise and connections exceeded expectations, making our success possible. Our relationship with PSC® has been phenomenal, significantly easing my workload.”

5.0

Victor Graham

QA Program Engineer III, Surgical
Johnson & Johnson Vision

“I had the pleasure of collaborating with PSC® for nearly two years on a critical validation project spanning Johnson and Johnson Surgical Vision sites globally. Their technical team developed comprehensive validation documentation and supported testing seamlessly. The project manager excelled in maintaining schedules, budgets, and providing guidance. PSC®’s professionalism and expertise fostered a highly efficient work environment, ensuring the project’s success.”

5.0