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
- Lockout/Tagout (LOTO) Procedures
- Performing training on the technical documents
- 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
- Environmental Monitoring Trend Reports
- Global Harmonization
- Installation, Operational, and Performance Qualification (IQ/OQ/PQ)
- Log Books
- Quality Manuals
- Regulatory Affairs
- Validation Master Plan Procedures
- White Papers
- Work Instructions
PSC Biotech® technical writing consultants also train on biomedical regulatory compliance documents by agencies such as the FDA, WHO, MHRA, EMA, and more. At PSC Biotech®, we are experts in drafting, editing, and reviewing technical documents, such as protocols, summary reports, product specifications, SOPs, quality manuals, validation master plans, and batch records. PSC Biotech® also reviews device history files and device master records for medical devices.
Technical writing is a core skill for our engineers, especially in Computer Systems Validation and Assurance (CSV/CSA) and Commissioning, Qualification, and Validation (CQV). PSC Biotech® manufacturing and CQV engineers excel at technical writing for life science companies to meet regulatory compliance. Many of our engineers and scientists focus solely on Technical Writing for controlled documents, work constructions, job aids, and more!
PSC Biotech® has a highly skilled team of Technical Writers that will ensure your qualification protocols and final reports are thorough and exceed expectations. Don’t have a document template yet? Our experts can deliver recommendations on report and protocol components to include and then customize these elements to your site and applications. Also, we provide expertise on existing documentation and improving compliance. Furthermore, PSC Biotech® has global regulatory compliance experience for global harmonization.
PSC Biotech® Industry Expertise
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals
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What Our Clients are Saying
“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.”
“The skillsets that PSC™ provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC™ was very independent and if we had an issue, PSC™ consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC™ are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC™. Just phenomenal! It made my life easier.”
“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.”