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.
Benefit- Risk Assessment for Regulatory process
Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics,...
Grant Writing For Regulatory Processes – Whitepaper
Grant writing is preparing and submitting proposals to secure funding from grant-making organizations such as government agencies, foundations, and...
Navigating Regulatory Inspections: Top 5 Remediation Best Practices
Regulatory compliance is essential in all industries, but it is easier said than done. Regulatory agencies strictly monitor organizations to ensure...
Annual Submissions for US in regulatory processes
Annual submissions to regulatory agencies in the US are required to maintain a product’s quality, safety, and efficacy throughout its lifecycle. These include the Annual Product Quality Reviews, Annual Safety Report, and others, each with different requirements based on the impact of changes made.
Maintaining Project Documentation and Records in Life Science
Life science companies deal with tons of data; this data could be related to processes (manufacturing, process controls, equipment, administrative,...
What is an Electronic Quality Management Software (QMS) Solution?
With the advent of global competition, maintaining quality standards has become increasingly important for companies in these industries. As a...
Guidance on Common Regulations and Standards
Whether a company is in the life science industry, or providing products in the pharmaceutical, biological, medical devices, cosmetics, veterinary...
Manufacturing Equipment and Laboratory Equipment Validations
With the advent of global competition, maintaining quality standards has become increasingly important for companies in these industries. As a...
Outsourcing Supplier Qualification and Auditing
If you work in the life science industry, you know how important it is to maintain the highest standards throughout your product's life cycle - from...
The 5 Most Common Data Migration Pitfalls
A Data migration is a daunting, but necessary task when companies undergo digital transformations. PSC Software®’s implementation experts have...
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...
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.
Canada
Consultant Locations: Vancouver, Toronto, Ottawa, Montreal, Calgary
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