software solutions

With PSC Software™’s cloud-based software solutions, your organization will be able to better operate ever-growing sensitive and confidential, quality dataset.

Professional Services

We offer specialized professional consulting for the world’s most highly regulated industries. Learn why were the premier consulting firm for the life science industry. 

 

equipment rentalS/sales

Our metrology unit is proud to be a distributor of validation equipment for use in the pharmaceutical, medical device, biotechnology, and diagnostics industries at a rental basis to fit the ever-changing needs of your company.

PSC™ Services

Quality Assurance/Compliance

QA review (GLP, GMP, GCP), 483/Warning Letter Remediation, Risk Assessments, EM Program Analysis/Creation

Audits

Supplier, Gap Analysis, Lab Audit, Facility, PAI prep, GLP, GMP, Data Integrity.

Metrology/Calibration

Equipment and instrument calibration services

Thermal mapping – Warehouse, Stability Chambers, etc.

Equipment Rental and Sales

Commissioning Qualification Validation

Potentially large complex projects where clients outsource facility commissioning, new production suite commissioning, Decommissioning, Method Validation, etc.

Technical Writing

Report writing, technical document writing expertise, FDA responses, SOP’s/Document/Forms, Safety Evaluations, Risk Mitigation

IT/IS

IT Analysis, Configuration, Validation, Project Management System Integrations

Engineering

Conceptual, Staff Augmentation, Process, Facilities, Equipment Selection, etc.

Safety Evaluations on processes and LOTO development.

Regulatory Affairs

ANDA / NDA Submissions to Regulator Bodies. Providing regulatory advice and practical assistance. FDA / EPA / OSHA / USDA / EU / etc.

Project Management

Provide expert oversight of IT, Engineering, C&Q and Validation projects

NEWS & BLOGS

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Quit Wasting Valuable Time; Electronic Systems are Here to Help!

Quit Wasting Valuable Time; Electronic Systems are Here to Help!

Written by: Andrea Salive, Business Development Manager The Life Science industry is making groundbreaking advances now more than ever and although rapidly evolving, there’s something the industry isn’t fully caught up to speed on- automated digital processes.   Gone...

Benefits of Renting CLiMET® Validation Equipment

Benefits of Renting CLiMET® Validation Equipment

CLiMET® particle counters and air samplers deliver precise test results so you can validate or monitor your clean rooms and controlled environments to get or stay compliant.   CLiMET® instruments are state-of-the-art, robust, and easy to use.   You should buy...

Not Performing a Risk Assessment is a Risky Business

Not Performing a Risk Assessment is a Risky Business

Written by: Wayne Berry, Quality Process and Computer Systems Validation Manager We perform risk assessments in every part of our life... choosing a safe car for our new teenage driver, making sure the car seat is properly secured for that newborn's first ride home,...

All Aboard! The Importance of Having a Proper On-Boarding Process

All Aboard! The Importance of Having a Proper On-Boarding Process

Written by: Priscilla Jones, Talent Acquisition Specialist  Many companies underestimate the importance of onboarding when they hire new employees. Several companies have no formal onboarding program at all, while most that do only have a partially successful process....

PSC Biotech™ (“PSC”) is Partnering with the Biotechnology Innovation Organization (BIO) to Provide Members Exclusive Cost Savings on Electronic Quality Management System Solutions and Computer System Validation Services

PSC Biotech™ (“PSC”) is Partnering with the Biotechnology Innovation Organization (BIO) to Provide Members Exclusive Cost Savings on Electronic Quality Management System Solutions and Computer System Validation Services

PSC Biotech™ (“PSC”), a global life sciences software solutions and consulting company, has partnered with the Biotechnology Innovation Organization (BIO) to offer members exclusive discounts on their industry leading software solutions and professional services. PSC...

Quit Wasting Valuable Time; Electronic Systems are Here to Help!

Auditing Services – Data Integrity

Data integrity has become crucial to compliance for regulated life science companies.   Data Integrity assures the completeness, consistency, accuracy, authenticity, timeliness, and reliability of your data. Whether your company is a biotechnology startup,...

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Our Offices Around The World

Singapore

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

Phone: +65 65158081

Website

Madison, Wisconsin

Dallas, Texas

Pomona, CA (Headquarters)

700 Corporate Center Drive
Pomona, CA 91768

Website

 

St Louis, Missouri

20 S Sarah St
Saint Louis, MO 63108

Website

Shanghai

Unit A423, No. 1 Tongxin Rd
Hongkou District, Shanghai, 200083, China

Phone: +86 21 66287876

Taiwan

1F., No. 55, Wenshan Rd., Qionglin Township, Hsinchu County 307, Taiwan (R.O.C.)

Phone: +886 900776016

Ireland

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

Phone: + 353 1 9011707

United Kingdom

Lower Catherine Street, Newry, County Down, BT35 6BE

Phone: +44 203 475 8107

Washington, DC

Chicago, IL

San Francisco, CA

Raleigh, NC

Netherlands

Switzerland

+41 445868156

Belguim

Pheonix, AR

Seattle, WA

Houston, TX

Austin, TX

United States

Headquarters: 700 Corporate Center Dr. Pomona, CA 91768

Phone: +1 (909) 784-3350
Fax: +1 (909) 784-3354
Email: info@biotech.com

Other Locations: San Francisco, CA. Dallas, TX. St Louis, MO. Chicago, IL. Madison, WI. Washington, DC. Raleigh, NC. Pheonix, AR. Seattle, WA. Houston, TX. Austin, TX.

Europe

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, N.Ireland, Netherlands
United Kingdom

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

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

Other Locations: Dublin, Switzerland, France, Germany, Spain, Italy, Netherlands, Poland, London, UK

Asia

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

Phone: +65 6515 8081

Other Locations: Singapore, Shanghai, Taiwan.