YOUR LIFE SCIENCE CONSULTING SOLUTIONS PARTNER

Contact Us

PSC BIOTECH®

Your Life Science Consulting Solutions Partner

Contact Us

Your Strategic Partner in Life Sciences

Global Compliance. Local Expertise. Trusted Experts.

At PSC Biotech®, we’re more than just consultants — we’re compliance experts. With a global presence and offices spanning across the Americas, UK, Ireland, Europe, Australia, Asia, and the Middle East, we bring local insight with worldwide expertise.

What sets PSC® apart?

Our team includes former FDA auditors and industry specialists with decades of real-world experience. From regulatory strategy to quality systems validation and calibration — we deliver customized solutions backed by real-world experience.

Whether you’re launching a new product, scaling operations, or navigating complex regulatory requirements, PSC Biotech® offers tailor-made solutions to help you succeed — every step of the way.

Partner with experience. Stay ahead with PSC Biotech®.

Solutions Provider​

Our service team focuses on partnering with you to refine your operation's execution, limit your organization’s risk, and improve general productivity. As your life science solutions partner, our engineering, technical, and consulting services incorporate all aspects of your operations.

schedule a consultatıon

Commissioning, Qualification, and Validation (CQV)

  • CQV for small- to large-scale engineering projects
  • CQV of facilities, utilities, equipment, laboratories, processes, cleaning, manufacturing lines, etc.​
  • Generation of deliverables from Validation Master Plan to Summary Reports​
  • Timely and cost-effective solution tailored to your company’s budget and requirements​
  • Decommissioning
Learn More

Computer System Validation (CSV)

  • CSV and CSA for enterprise applications, analytical equipment software, etc.​
  • Risk Assessment and Data Integrity​
  • Development of CSV or CSA policies and procedures​
  • QMS, ERP, LIMS, MES, Clinical, and more
Learn More

Audits

  • Global auditing capability, leveraging global team​
  • Audit types: supplier, gap analysis, risk assessments, lab audits, PAI prep, GLP, GMP, data integrity, and CSV​
Learn More

Metrology/Calibration

  • Equipment and instrument calibration services​
  • ISO Certified​
  • On-site service or at PSC® metrology laboratories​
  • Thermal mapping – warehouse, stability chambers, freezers, refrigerators, etc.​
  • Equipment rentals and sales​​​
Learn More

Quality Assurance/Compliance

  • Full range of QA Services for GxP​
  • Guidance, review, policy and procedure development​
  • 483/Warning letter remediation​
  • Change Control, Risk Management, Deviations and CAPAs, Quality Agreements, Training, Audits​​
Learn More

Technical Writing

  • Report writing
  • Technical document writing
  • FDA Response Letters
  • Policies, SOPs, documents, and forms
  • Protocols, methods, and specifications
Learn More

Project Management

  • Provide full-service project management from conception to implementation​
  • Scope, budget, scheduling, resources, stakeholders, etc.​
  • Provide expert oversight of IT, engineering, and CQV projects​
Learn More

Engineering Support

  • Full engineering service from concept to implementation​
  • Facility design​
  • Equipment selection​
Learn More

Regulatory Affairs

  • Support ANDA/NDA Submissions to Regulatory Bodies​
  • Provide regulatory advice and practical assistance​
  • FDA, EPA, OSHA, USDA, EU, etc.​​​​
Learn More

What Our Clients are Saying

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

Emerson Perin, MD, Phd

Quality Manager
MD Texas Heart Institute

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

5.0

Tiffanie Browne

Supply Chain Manager
Takeda

“PSC®’s regulatory support was instrumental in overcoming a significant obstacle. 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. PSC®’s professionalism and expertise fostered a highly efficient work environment, ensuring the project’s success.”

5.0

Located Globally

30+ Countries Worldwide

Pomona, CA, USA

San Francisco, CA, USA

Dallas Street, La Mesa, CA, USA

San Luis Pass, TX, USA

Chicago - Kansas City Expressway, Hannibal, MO, USA

Madison, IL, USA

Washington Island, WI, USA

Dupont Circle, Raleigh, NC, USA

Phoenix, NC, USA

Seattle Espresso Inc., East Warner Road, Tempe, AZ, USA

Houston TX Hot Chicken, North Ruby Street, Spokane, WA, USA

Austin, TX, USA

Denver City, TX, USA

Salt Lake City, UT, USA

Orlando, FL, USA

Puerto Rico

Canada

Virginia, USA

Wisconsin, USA

Connecticut, USA

Oregon, USA

Mississippi, USA

Maryland, USA

Missouri, USA

Indiana, USA

South Carolina, USA

Alabama, USA

Georgia, USA

New Mexico, USA

Tennessee, USA

Louisiana, USA

Minnesota, USA

Kentucky, USA

New Jersey, USA

Ohio, USA

Massachusetts, USA

Michigan, USA

Maryland, USA

Germany

Switzerland

Spain

Italy

France

Poland

UK

Netherlands

Belgium

Montenegro

26 Boon Lay Way, Trade Hub 21 #01-92 Singapore 609970

Shanghai, China

Taiwan

Singapore

Japan

South Korea

Malaysia

Beijing, China

India

Monash Innovation Labs, Building 69 (Suite G54), 22 Alliance Lane, Clayton VIC 3168

Brisbane QLD, Australia

Tel Aviv, Israel

Tel Aviv, Israel

2002-2006, 20th Floor, The Exchange Tower, Business Bay, Dubai, United Arab Emirates

2002-2006, 20th Floor, The Exchange Tower, Business Bay, Dubai, United Arab Emirates

London, UK

Lower Catherine Street, Newry, UK

Headquarters: 700 Corporate Center Drive, Pomona, CA 91768

Phone: +1 (909) 784-3350
Email: sales@biotech.com

Other Locations: Alabama, Arizona, California, Canada, Colorado, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Washington, D.C., and Wisconsin

Headquarters: PSC Biotech Ltd Unit 8, Block 8, Blanchardstown Corporate Park 1 Ballycoolin, Blanchardstown, Dublin 15, D15 N127 Ireland

Phone: +353 1 9011707
Email: europehr@biotech.com

Other Locations: Germany, Switzerland, Spain, Italy, France, Poland, UK, Netherlands, Belgium, Montenegro

Headquarters: 26 Boon Lay Way, Trade Hub 21 #01-92
Singapore 609970

Phone: +65 6515 8081

Email: singapore_sales@biotech.com (Singapore) taiwan_sales@biotech.com (Taiwan)

Other Locations: Singapore, Shanghai, Taiwan, Japan, South Korea, Malaysia, Beijing, India

Headquarters: Monash Innovation Labs, Building 69 (Suite G54), 22 Alliance Lane, Clayton VIC 3168

Phone: +61 3 9800 6200

Email: australiapsc@biotech.com

Headquarters: Tel Aviv, Israel

Location: 2002-2006, 20th Floor, The Exchange Tower, Business Bay, Dubai, United Arab Emirates

Headquarters: PSC Biotech Ltd, Lower Catherine Street, Newry, Co Down, BT35-6BE, N. Ireland

Phone: +44 203 4758107
Email: europehr@biotech.com

Other Locations: London