At PSC Biotech™, we are firm believers in offering top-notch specialized professional consulting for highly regulated industries. That is why, as PSC Biotech™, we have come to be known as the premier consulting firm for the life science industry. What’s more is that we know that as the landscape of this business is ever-changing, laser-focused attention on the regulatory landscape, speed-to-market, the balance between safety and efficacy.

We place great focus on helping your organization make the most of opportunities with specialized consultants, all the while, ensuring you benefit through the implementation of scalable solutions related to delivery, continuous improvement, and of course, innovation.

The Industries We Serve

Our team is passionate about addressing the needs that are unique to:

  • Pharmaceutical
  • Biopharmaceutical
  • Biotechnology
  • Biologics
  • Personalized medicine
  • Nutraceuticals
  • Diagnostics
  • Homeopathic
  • Blood banks
  • Medical device
  • Cell therapy
  • Gene therapy

PSC Biotech™ can offer end-to-end solutions—no matter if your project is small and short term or if it is an engagement that will last months or years. It is our intent to act as your trusted partner today, tomorrow, and well into the future.

Why Choose PSC Biotech™?

PSC Biotech™’s approach is based on current GMP, GAMP 5, ISO, and 21 CFR Part 11 regulations. We offer leading-edge professional consulting to address challenges in:

  • Validation
  • Computer systems validation
  • Compliance and technical management
  • Quality systems
  • Documentation protocol
  • Regulatory affairs
  • IT enterprise systems for GxP facilities
  • Lab services
  • Training programs
  • GLP/GCP services
  • Facilities support services
  • Engineering support services
  • Commissioning, qualification and validation
  • Quality systems implementation and design
  • Quality and document management system selection
  • Design reviews
  • Supplier quality audits
  • Mock FDA inspection tools, best practices and readiness assessments
  • Lab instrument qualification
  • Laboratory IT/IS systems
  • Workflow automation assessments, tools and implementation

It is our goal to enable your company’s success as you attain your vision. Furthermore, because we have worldwide capabilities, employ thousands of skilled experts, and have a solid organizational foundation, you will gain a competitive edge through a turnkey approach designed to fit your needs.

To view our career offerings, please click here for the US and here for the EU.