Technical Writing

Trained in Good Documentation Practices (GDP)

psc bıotech

PSC Biotech® technical writers deliver expertise and services, from configuring templates to reviewing existing documentation

Ensure regulatory compliance by utilizing our technical writers and engineers.


With over 25 years of experience in life science manufacturing regulatory compliance, PSC Biotech® understands the precision required for technical writing. PSC Biotech® technical writing consultants know that documentation is critical for all steps in pharmaceutical and medical device development and production. Therefore, our technical writing consultants strictly follow Good Documentation Practices (GDP), which is necessary for GLP and GMP compliance.

  • FDA Submissions
  • Investigations
  • Lockout/Tagout (LOTO) Procedures
  • Manuals
  • Performing training on the technical documents
  • Protocols
  • Specifications
  • Standard Operating Protocols (SOPs)
  • Summary Reports
  • Training documentation creation
  • Batch Records
  • Clinical Operations
  • Commissioning, Qualification, and Validation (CQV)
  • Data Science
  • Device History Files
  • Device Master Records
  • Engineering
  • Environmental Monitoring Trend Reports
  • Forms
  • Global Harmonization
  • Installation, Operational, and Performance Qualification (IQ/OQ/PQ)
  • Log Books
  • Manufacturing
  • Methods
  • Quality Manuals
  • Regulatory Affairs
  • Reports
  • Validation Master Plan Procedures
  • White Papers
  • Work Instructions
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.


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Related Project

Commissioning of the new manufacturing science and technology (MSAT) lab.
Commissioning Project Summary Qualification Validation

Commissioning of the new manufacturing science and technology (MSAT) lab.

PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process. This helped our CQV experts to directly start and complete the project.

Commissioning Of The New Apheresis Inspection And Processing Spaces
Commissioning Project Summary Qualification Validation

Commissioning Of The New Apheresis Inspection And Processing Spaces

The commissioning team successfully completed the modifications to the air handling system according to the client’s specifications and design. They checked the changes to the supply and return ductwork, as well as the new and existing variable air volume boxes.

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