Our Services
Our services focus on refining your operations execution, limiting your organization’s risk, and expanding general productivity. As your life science solutions partner- our engineering, technical and consulting services incorporate all aspects of operation.
ACE® Announces New Language Support
We’ve added 6 new languages to the suite of PSC Software® applications. Adaptive Compliance Engine® (ACE® ) and AuditUtopia powered by ACE® now...
ACE® now available as an App!
ACE® Mobile App is the latest addition to PSC Software®’s suite of eQMS solutions and is available for Apple iOS and Android devices. As an ACE...
Difference Between CTD and eCTD Submission Formats
What is an eCTD submission? The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document...
How to Ace Your Inspections: Keys to Inspection Readiness
On-site and Remote Inspection Management Regulatory inspections can be some of the most intense and stressful activities on a highly regulated...
PSC Biotech welcomes Korey Fleck as Vice President of Solution Architects to Spearhead Continued Growth in Life Science
PSC Biotech® welcomes Korey Fleck as Vice President of Solution Architects as of September 12, 2022. Korey comes to PSC Biotech with over 20 years...
Four New Free Features to ACE Software Customers
POMONA, CA (AUGUST 31, 2022) PSC Software® is excited to provide our ACE® electronic Quality Management System (eQMS) customers with four powerful...
Structure of the Common Technical Document (CTD)- M4 Guideline
What is the Common Technical Document (CTD)? The Common Technical Document (CTD) format or dossier was designed by the ICH and was agreed upon as a...
Top 2 FDA Citations to Avoid
The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or...
Innovations in Validation: Advancing Cell and Gene Therapies
With the ever-changing mechanics of innovation in the manufacturing environment, work from home and federal regulation validation strategies need to...
Use of Multi-Disciplinary Validation Teams for GXP Projects White Paper
Maximize efficiency and effectiveness in your validation projects by utilizing multi-disciplinary teams. The term "Validation," as used in this...
Nonstop Growth in 52 Countries Produces Multiple Careers within PSC Biotech®
PSC Biotech® has offices across North America, Europe, and Asia. PSC operates in 52 countries globally and has served thousands of clients to date....
Quality Risk Management for Commissioning and Qualification
Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV)...
Inspections and Audits: What You Need to Know
Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit...
Cybersecurity | Keeping your data safe with eQMS
Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US...
The Pitfalls of Data Migration
Did you know that the FDA regulates data integrity? Pharmaceutical and Medical Device industries must operate in accordance with current Good...
We’re Located Globally
+30 Countries Worldwide
United States
Office Locations (with Consultants): Pomona, CA. San Francisco, CA. Dallas, TX. St Louis, MO. Chicago, IL. Madison, WI. Washington, DC. Raleigh, NC. Phoenix, AZ. Seattle, WA. Houston, TX. Austin, TX. Denver, CO. Salt Lake City, UT. Orlando, FL.
Consultant Locations: Canada, Puerto Rico, Virginia, Wisconsin, Connecticut, Oregon, Mississippi, Maryland, Missouri, Indiana, South Carolina, Alabama, Georgia, New Mexico, Tennessee, Louisiana, Minnesota, Kentucky, New Jersey, Ohio, Indiana, Massachusetts, Michigan, Maryland.
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
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, London
Asia
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
Middle East
Headquarters: Tel Aviv, Israel
Other Locations:Israel, Montenegro, India
Australia
Headquarters: Melbourne, Australia
Phone:+61 421 390 419
Email: Aus_Sales@biotech.com