About PSC Biotech®

Who we are

psc bıotech

PSC Biotech® Company Overview

Founded in 1996, PSC Biotech® has spent more than two decades providing life sciences with essential services to ensure that healthcare products are developed, manufactured, and distributed to the highest standards in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success. To achieve this, our method is straightforward; we put the client’s needs first. We attain top-tier expertise for each project stage, from generating comprehensive project plans to reaching extensive production operations into attentive asset management, authenticity, and non-expendable ventures.

Since our inception, PSC Biotech® has served as a strategic partner to emerging and established life science companies, all to help bring their life-saving products to market. PSC Biotech® operates in 52 countries globally and has served thousands of clients. Employing a global team of skilled professionals and experts that span strategically located offices in North America, Europe, Asia, and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

Who we are

Our Mission

We are driven by the mission of steady, organic global growth and development by exercising the highest level of integrity and delivering the utmost professionalism through our products and services.

We understand that the field of life sciences is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations. We are dedicated to ensuring our expertise and products remain world-class, and we continually invest in our people through internal and external training to ensure they are up to date on the current regulations and technologies.

We believe that we should promote from within and create high-performing teams that can be assembled quickly to meet our clients’ expectations regarding the quality of deliverables, stay under budget, and ensure timelines for our deliverables are being met.

We accelerate with our trusted partners

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CLIENT Testimonial

What Customers Are Saying

We Take Pride in the Relationships We Build and the Solutions We Provide

“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.”

Steve Lawson

Senior Quality Assurance Engineer
Biomedical Manufacturer

“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.”

Chris Brady

Manager, Facilities Engineering
Illumina

“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.”

Jeff Yuen, MPH, MBA

Former Commander Food and Drug Administration

“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.”

Angele Zaboura

General Manager
Beit Jala Pharmaceutical

“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.”

Sharon Fisher

Quality Manager
MicroGEM

“I cannot recommend anyone more highly than I recommend PSC™. They have been a god-send.”

Emerson Perin, MD, PhD

Quality Manager
MD Texas Heart Institute

“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.”

Tiffanie Browne

Supply Chain Manager
Takeda

“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.”

Victor Graham

QA Program Engineer III, Surgical
Johnson & Johnson Vision

how can we help you

Contact PSC Biotech Corporation Today!

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About PSC Biotech®

psc bıotech

PSC Biotech® Company Overview

Who we are

Our Mission

We accelerate with our trusted partners

CLIENT Testimonial

What Customers Are Saying

how can we help you

Contact PSC Biotech Corporation Today!

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