Your Life Science Consulting

PSC Biotech®

Solutions Partner

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software solutions

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

We offer specialized life science consulting services and solutions for the world’s most highly regulated industries. We’re the premier consulting firm for the life science industry.

 

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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.
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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. 

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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Metrology/Calibration

Equipment and instrument calibration services

Thermal mapping – Warehouse, Stability Chambers, etc.

Equipment Rental and Sales

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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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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.

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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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Trusted Partners

Trade Association, Equipment, Incubator, Government Agency and
University are some of our partner categories. Become A Partner Today!

 

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NEWS & BLOGS

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How PSC® Brings Value to Incubators

How PSC® Brings Value to Incubators

Apr 1, 2021 |

Written By: Erin Li, Channel Partnership Intern, PSC Biotech® PSC Biotech® (“PSC®”) is a global life sciences software solutions and consulting...

A Penny Saved is a Penny Earned. The Importance of Staying on Track and on Project Costs on Large Complex Projects

FDA Combination Products Q&A

Feb 11, 2021 |

Written By: Jorge Sugranes, Regional Director of Latin America, PSC BiotechHere are some Q&A regarding combination products (CP) that you might...

Why is Data Integrity Vital

Why is Data Integrity Vital

Jan 28, 2021 |

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech CorporationData Integrity is a point of emphasis for the US FDA.  That means they...

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We're Located Globally

+30 Countries Worldwide

 

Title Address Description
Our Headquarters
700 Corporate Center Dr, Pomona, CA 91768, USA
STL, MO
St. Louis, MO, USA
Chicago, IL
Chicago, IL, USA
Madison, WI
Madison, WI, USA
Washington, DC
Washington, USA
Raleigh, NC
Raleigh, NC, USA
Pheonix, AZ
Phoenix, AZ, USA
Seattle, WA
Seattle, WA, USA
Dallas, TX
Dallas, TX, USA
Denver, CO
Denver, CO, USA
Florida
Florida, USA
Germany
Germany
Ireland
Ireland
Switzerland
Switzerland
Italy
Italy
Spain
Spain
France
France
Poland
Poland
Netherlands
Netherlands
London
London, UK
Singapore
Singapore
China
China
Canada
Toronto, ON, Canada
PR
Puerto Rico
Virgina
Virginia, USA
Connecticut
Connecticut, USA
Oregon
Oregon, USA
Maryland
Maryland, USA
Pennsylvania
Pennsylvania, USA
Massachusetts
Massachusetts, USA
New Jersey
New Jersey, USA
Ohio
Ohio, USA
Indiana
Indiana, USA
San Francisco, CA
San Francisco, CA, USA
Los Angeles, CA
Los Angeles, CA, USA
Orange County, CA
Orange County, CA, USA
San Diego, CA
San Diego, CA, USA
Houston, TX
Houston, TX, USA
Austin, TX
Austin, TX, USA
Fort Worth, TX
Fort Worth, TX, USA
Boston, MA
Boston, MA, USA
Belgium
Belgium
Japan
Japan
South Korea
South Korea
Malaysia
Malaysia
Beijing
Beijing, China
Tel Aviv, Israel HQ
Tel Aviv-Yafo, Israel
Israel
Israel
Montenegro
Montenegro
India
India
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. Orlando, FL.

Consultant Locations: Canada, Puerto Rico, Virginia, Wisconsin, Connecticut, Oregon, Mississippi, Maryland, New Jersey, Ohio, Indiana, 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

 

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

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

Middle East

Headquarters: Tel Aviv, Israel

Other Locations:Israel, Montenegro, India