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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WHITEPAPER

Download Our How to Write a White Paper one-pager

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CLIENT Testimonial

What Customers Are Saying

We Take Pride in the Relationships We Build and the Solutions We Provide

“A successful regulatory audit demands meticulous planning, defined roles, and effective communication. AuditUtopia® stands out as the most effective software tool for optimizing communication channels, enabling timely responses and evidence provision. It empowers the right resources within the organization to address auditor inquiries efficiently. With AuditUtopia®, I’ve navigated multiple intense audits with confidence and wouldn’t be without it.”

Steve Lawson

Senior Quality Assurance Engineer
Biomedical Manufacturer

“I am very happy with the services that PSC™ has provided. They have helped me here in San Diego and at our Madison site for many years now. They have provided highly-skilled validation specialists that have complemented our full time work force.”

Chris Brady

Manager, Facilities Engineering
Illumina

“Seasoned individuals are crucial for successful FDA inspections, managing various tasks seamlessly. AuditUtopia™ has proven its value in streamlining the inspection process, tested in simulated FDA mock inspections. As a former FDA investigator, I wholeheartedly endorse AuditUtopia® for regulated industries. Its efficiency will impress any FDA investigator, ensuring smooth inspection management—an essential bottom line.”

Jeff Yuen, MPH, MBA

Former Commander Food and Drug Administration

“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.”

Angele Zaboura

General Manager
Beit Jala Pharmaceutical

“During the past year, our company has been working with PSC™ on various activities within the development and implementation of a new medical device product. PSC™ offers high quality services, and we can say that we have always been satisfied by their work.”

Sharon Fisher

Quality Manager
MicroGEM

“I cannot recommend anyone more highly than I recommend PSC™. They have been a god-send.”

Emerson Perin, MD, PhD

Quality Manager
MD Texas Heart Institute

“PSC™’s regulatory support was instrumental in overcoming a significant obstacle. Their independent approach, willingness to collaborate cross-functionally, and great communication eliminated the need for micromanagement. With minimal supervision, their expertise and connections exceeded expectations, making our success possible. Our relationship with PSC™ has been phenomenal, significantly easing my workload.”

Tiffanie Browne

Supply Chain Manager
Takeda

“I had the pleasure of collaborating with PSC™ for nearly two years on a critical validation project spanning Johnson and Johnson Surgical Vision sites globally. Their technical team developed comprehensive validation documentation and supported testing seamlessly. The project manager excelled in maintaining schedules, budgets, and providing guidance. PSC™’s professionalism and expertise fostered a highly efficient work environment, ensuring the project’s success.”

Victor Graham

QA Program Engineer III, Surgical
Johnson & Johnson Vision

OUR projects

Related Project

CSV Project Summary

Computer System Validation for a Pharmaceutical Client

November 7, 2023May 23, 2024

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.

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

October 23, 2023May 24, 2024

Commissioning Project Summary Qualification Validation

Commissioning Of The New Apheresis Inspection And Processing Spaces

October 17, 2023May 23, 2024

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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