Engineering

Our Key Area of Life Science Services

psc bıotech

PSC Biotech® Engineering consultants assist life science companies in meeting regulatory compliance with CQV and more.

PSC Biotech® Engineers take a risk-based approach; thus, we always work with ICH Q9 guidelines in place. We have qualified and experienced engineers in over 35 countries to serve your new, existing, or decommissioning production site.

  • cGMP Engineering Services
  • Engineering Support
  • Engineering Drawings
  • Engineering SOPs
  • Redline Piping and Instrumentation Diagrams (P&IDs)
  • Support Preventative Maintenance Services
  • Equipment Commissioning, Qualification, and Validation
  • Software Validation
  • Metrology and Calibration
  • Serialization
  • Product Specifications
  • Hazard Analysis
  • Engineering Program Management
  • Certification Programs for Capital Projects
  • Lifecycle Management for Process, Facility, and Utility Systems
  • Program Management and Governance for engineering projects
  • Ensure compliance with Environmental Health and Safety (EH&S)
  • Technical Documentation and Writing – SOPs / LOTO Procedures / Global Harmonization / Risk Assessments
  • Training documentation creation and performing training
  • Design creation and review for early project stages (room classification, P&ID review, creation of review, etc.

psc bıotech


PSC Biotech® Industry Expertise

Cosmetics, Cannabis
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals

PSC Biotech® Engineers work to your project needs. See our project success pages for examples. To start the process of gaining a PSC Biotech® Engineer to design, validate, implement, optimize, or otherwise assist in your engineering project, contact us today!

LIFE SCIENCE EXPERTISE ON DEMAND

What makes PSC Biotech® the partner of choice for leading life science companies? It’s our full-service approach to ensuring your facilities, equipment and processes meet regulations set by leading regulatory bodies. Access the full spectrum of software and service solutions your company needs to thrive. Contact a PSC expert today.

psc bıotech

Global Engineering Excellence for Life Sciences Compliance

We have qualified and experienced engineers in over 50 countries to serve your new, existing, or decommissioning production site. At PSC Biotech®, our Engineers focus on the engineering needs of pharmaceutical and medical device manufacturing in the life sciences. At the core, PSC Biotech® Engineers take a risk-based approach; thus, we always work with ICH Q9 guidelines in place. PSC Biotech® Engineers assist with cGMP FDA compliance, EMA compliance, MHRA compliance, and other regulatory standards as required.

Additionally, PSC Biotech® assigns a Project Manager to each Engineering project. The Project Manager utilizes our exclusively developed Project Tracker software to maintain an accurate and up-to-date deliverable document status. With years of expertise and regulatory awareness, our engineers execute projects in a highly efficient manner to meet your needs as soon as possible. See our project success pages for examples. Contact us for a customized assessment and cost estimate.

As an example of PSC Biotech® Engineer’s focus on Quality, Validation, and Documentation, here are some ways we’ve helped clients and what we can do for you:

  • 21 CFR Part 211/210/820, ISO 13485, and FDA regulation compliance
  • Developing, amending, and implementing standard GMPs/SOPs
  • Implementing continuous improvements
  • Developing and improving production processes
  • Conducting complaint investigations and audits
  • Performing root cause analysis/NCRs for production
  • Resolving quality issues
  • Conducting engineering analyses
  • Sterilization – Autoclaves, Sterilization-In-Place (SIP), Clean-In-Place (CIP), freezers, Lyophilization Cabinets, Ointment Filler, and other Aseptic Equipment
  • Laboratory and Production equipment –Bioreactors, HPLCs, GCs, FTIR, ovens, filling machines, process mixers, process tanks, and freezers
  • Utilities – Electrical, Compressed Air, Nitrogen Systems, and HVAC
  • Drafting, editing, reviewing, and executing protocols
  • Compliance – cGMP, SOPs, batch records, validation documents
  • Reviewing 21 CFR Part 211/210/820, ISO 13485, and FDA regulation adherence
  • Functional specifications, systems designs, and process flow diagrams
  • Transferring existing protocols to new standard templates,
  • Developing new manufacturing processes and equipment technologies,
  • Designing and qualifying new processes
  • Developing training material
  • Creating test method protocols
  • Writing master validation plans
  • Master validation schedules

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