YOUR LIFE SCIENCE CONSULTING SOLUTIONS PARTNER

PSC BIOTECH®

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.

Quality Assurance/Compliance

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

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

Potentially large, complex projects where clients outsource facility commissioning, new production suite commissioning, decommissioning, method validation, etc.
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Technical Writing

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

Conceptual, Staff Augmentation, Process, Facilities, Equipment Selection, etc.
Safety Evaluations on processes and LOTO development.
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Regulatory Affairs

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

Provide expert oversight of IT, Engineering, C&Q and Validation projects.
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Manufacturing Execution System (MES)

Custom solutions for automatically managing material inventory, product orders, and work protocols.
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Metrology/Calibration

Equipment and instrument calibration services
Thermal mapping – Warehouse, Stability Chambers, etc.
Equipment Rental and Sales.
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Trade Association Partners

Government Agency Partners

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Incubator Partners

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Equipment Partners

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University Partners

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CLIENT Testimonial

What Customers Are Saying

We Take Pride in the Relationships We Build and the Solutions We Provide

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“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.”
Steve Lawson
Senior Quality Assurance Engineer
Biomedical Manufacturer
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“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.”
Chris Brady
Manager, Facilities Engineering
Illumina
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“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.”
Jeff Yuen, MPH, MBA
Former Commander Food and Drug Administration
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“Just wanted to express my gratitude for AuditUtopia®! During a recent FDA PAI inspection with 211 document requests, it proved indispensable. Our Quality staff executed FDA requests swiftly and flawlessly, facilitating real-time communication across groups and reducing overall stress. Thanks to AuditUtopia®, the inspection was a success—we obtained our commercial license, with AuditUtopia® playing a significant role in achieving this milestone.”
EJ Brandreth
Vice President of Quality & Regulatory
Inovio Pharmaceuticals Inc.
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“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.”
Angele Zaboura
General Manager
Beit Jala Pharmaceutical
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“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.”
Sharon Fisher
Quality Manager
MicroGEM
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“I cannot recommend anyone more highly than I recommend PSC™. They have been a god-send.”
Emerson Perin, MD, PhD
Quality Manager
MD Texas Heart Institute
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“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.”
Tiffanie Browne
Supply Chain Manager
Takeda
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“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.”
Victor Graham
QA Program Engineer III, Surgical
Johnson & Johnson Vision

our resources center

Resources

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
News Release

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

News Release

Learn More PSC Biotech™ (“PSC”), a global life sciences software solutions and consulting company, has partnered with the Biotechnology Innovation Organization…

our resources

offıces

We’re Located Globally

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: Melbourne, Australia

Phone: +61 3 9800 6200

Email: australiapsc@biotech.com/

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, Netherlands, Belgium

Headquarters: Tel Aviv, Israel

Other Locations: Israel, Montenegro, 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: Dublin, London

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.