YOUR LIFE SCIENCE CONSULTING SOLUTIONS PARTNER

Contact Us

Resources

Get The Latest Blog Post

OUR RESOURCES CENTER

BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Navigating Regulatory Inspections: Top 5 Remediation Best Practices

Navigating Regulatory Inspections: Top 5 Remediation Best Practices

Mar 10, 2023 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Annual Submissions for US in regulatory processes

Annual Submissions for US in regulatory processes

Feb 14, 2023 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Maintaining Project Documentation and Records in Life Science

Maintaining Project Documentation and Records in Life Science

Feb 2, 2023 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
What is an Electronic Quality Management Software (QMS) Solution?

What is an Electronic Quality Management Software (QMS) Solution?

Jan 26, 2023 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Guidance on Common Regulations and Standards

Guidance on Common Regulations and Standards

Jan 11, 2023 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Manufacturing Equipment and Laboratory Equipment Validations

Manufacturing Equipment and Laboratory Equipment Validations

Jan 5, 2023 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Outsourcing Supplier Qualification and Auditing

Outsourcing Supplier Qualification and Auditing

Dec 19, 2022 Read more
White Paper https://biotech.com/wp-content/uploads/2024/06/icon1-13.svg
The 5 Most Common Data Migration Pitfalls

The 5 Most Common Data Migration Pitfalls

Dec 5, 2022 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Difference Between CTD and eCTD Submission Formats

Difference Between CTD and eCTD Submission Formats

Oct 24, 2022 Read more
White Paper https://biotech.com/wp-content/uploads/2024/06/icon1-13.svg
How to Ace Your Inspections: Keys to Inspection Readiness

How to Ace Your Inspections: Keys to Inspection Readiness

Oct 11, 2022 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Inspections and Audits: What You Need to Know

Inspections and Audits: What You Need to Know

Apr 14, 2022 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Cybersecurity | Keeping your data safe with eQMS

Cybersecurity | Keeping your data safe with eQMS

Apr 7, 2022 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
The Pitfalls of Data Migration

The Pitfalls of Data Migration

Mar 31, 2022 Read more
White Paper https://biotech.com/wp-content/uploads/2024/06/icon1-13.svg
Use of Multi-Disciplinary Validation Teams for GXP Projects White Paper

Use of Multi-Disciplinary Validation Teams for GXP Projects White Paper

Mar 12, 2022 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
Paperless Validation – What is it and why you need it

Paperless Validation – What is it and why you need it

Mar 10, 2022 Read more
BLOG https://biotech.com/wp-content/uploads/2024/06/icon1-12.svg
It’s a GMP Kind of Thing

It’s a GMP Kind of Thing

Mar 3, 2022 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