Documentation and Technical Writing

Regulatory documentation serves two masters: it must satisfy inspectors, and it must guide the people who do the work. Documentation that achieves one but not the other fails at its purpose. We write documents that are both compliant and practical.

Standard Operating Procedures (SOPs)

SOPs are the backbone of any regulated operation. We write procedures that reflect how work actually gets done — not idealized versions that sit in binders while operators develop their own workarounds.

• Manufacturing and packaging SOPs
• Laboratory testing and method procedures
• Quality system procedures (CAPA, deviation, change control, complaint handling)
• Equipment operation and maintenance procedures

Regulatory Submissions

Regulatory submissions require a specific kind of writing: precise, evidence-based, and structured to facilitate reviewer assessment. We prepare submission documents that present your data clearly and address regulatory expectations directly.

• 510(k) and PMA submission documents
• Technical files for EU MDR/IVDR
• Design history files (DHF)
• Risk management files per ISO 14971
• Clinical evaluation reports (CER)

Validation Documentation

Validation protocols and reports must demonstrate that your processes, equipment, and systems consistently produce results meeting predetermined specifications. We write validation documentation that is scientifically sound and audit-ready.

• IQ/OQ/PQ protocols and reports
• Process validation protocols (PPQ)
• Cleaning validation documentation
• Computer system validation (CSV) documentation
• Method validation protocols

Audit-Ready Documentation Packages

When you know an inspection is coming, your documentation needs to be organized, current, and defensible. We prepare documentation packages that present your quality system in the best accurate light.

• Document review and gap remediation
• Master document index and organization
• Controlled document system setup
• Record retention and retrieval procedures

Our Writing Standards

Every document we produce meets these criteria:

• Clear — written for the intended audience, not to impress
• Accurate — reflects actual processes and current requirements
• Complete — addresses all applicable regulatory expectations
• Controlled — fits within your document control system
• Maintainable — structured so your team can update it as processes evolve