Your Solutions Partner
The Life Science Sectors We Serve
Our team is passionate about addressing the needs that are unique to:
- Medical device
- Personalized medicine
- Blood banks
- Cell therapy
- Gene therapy
Food and Beverage
What Our Clients are Saying
“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.”
“I had the pleasure of working with the PSC staff for nearly two years on a high visibility validation project that impacted all of the Johnson and Johnson Surgical Vision sites around the world.
The completion of this project was vital to maintaining the validation status of hundreds of systems and applications used in a variety of activities in Research & Development, Chemistry, Marketing, Supply Chain, and so on. The PSC Technical Staff was able to develop validation documentation (Compliance Assessments, Plan, Protocols, Scripts) in conjunction with the business groups, was able to support execution of System and User Acceptance testing, and was able to draft and submit Test Reports, Traceability Matrices, and Summary Reports for each of the applicable Non-Product Software systems and applications.
The PSC Project Manager did an excellent job in maintaining schedules, adhering to timelines, providing weekly summaries, tracking budgets and expenditures, and providing guidance, not only to the Technical Staff but also myself.
The professionalism, attitude, and expertise of the PSC staff enabled a cooperative and efficient work environment that performed at a very high level.”
“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia™ has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia™ and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”