PSC Biotech^® technical writers have provided specialized expertise to support the life science industry’s documentation needs, ensuring clarity, compliance, and effectiveness. Our consultants integrate seamlessly into your team to create and review content that aligns with regulatory requirements and industry standards, adhering strictly to Good Documentation Practices (GDP) in compliance with GLP and GMP. From configuring templates to developing and revising documents such as SOPs, Work Instructions, Validation Protocols, URS, Risk Assessments, Investigational Reports, training materials, and engineering drawings, we deliver high-quality documentation that supports your operational and regulatory success.

• Standard Operating Procedures (SOPs)
• Work Instructions (WIs)
• Validation Protocols and Reports
• User Requirement Specifications (URS)
• Risk Assessments
• Investigational Reports
• Training materials
• Engineering drawings & specifications

Our experienced consultants provide comprehensive support across the full lifecycle of Technical Writing for ensuring regulatory compliance, product quality, patient safety, and effective communication across your business.