Regulatory Writing

Expertise in the Disciplines Regulatory Compliance Demands

Compliance in the medical, financial, and pharmaceutical industries is law. It requires regulatory writing experts to meet these stringent documentation demands. We are masters of precision, and we are experienced in writing and editing to regulatory requirements.

A Reputation for Excellence

TRA360 started its regulatory writing practice six years after our founding in 1997. We are committed to acting as a go-to resource for clients, working with you to develop document content and format that demonstrate compliance with the global regulatory requirements of the US FDA, EU EMA, and Japanese PMDA.

Regulatory affairs writing is a process that produces results. Together, we can review your current practices, documents, and training. We can step back, and review the regulations in the context of your business. We can identify gaps in your current processes, documentation, and business practices. Furthermore, if asked, we can make and give recommendations on how to proceed, engaging key stakeholders across your business units, CROs, and partners.

Vital Documents, Demanding Schedules, and On-Time Delivery

Regulatory writing has strict schedules. Missing any approved milestone date ensures that the document will be moved to the end of the line, potentially having a negative financial impact on your company and its reputation. There are ways of preventing this, and we use them. We take care to develop exact regulatory documents on time that are in compliance with industry regulations.

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TRA360 Regulatory Writing Products

  • 510(k) Submissions
  • Application Functionality Tests and Scripts
  • Clinical Summaries
  • Common Technical Documents (CTDs)
  • Computer Systems Validation (CSV) Documents
  • Clinical Study Reports (CSR)
  • Detailed Design Specifications (DDS)
  • Electronic Common Technical Documents (eCTD)
  • Final Summary Reports
  • Functional Specifications
  • Gap Analyses
  • Informed Consents (IC)
  • Instructions for Use (IFU)
  • Investigator’s Brochures (IB)
  • Investigational New Drug Applications (IND)
  • Installation Plans and Reports
  • Installation Qualifications (IQ)
  • Installation Verifications (IV)
  • Job Aids
  • Lab Equipment Validation Documents
  • Maintenance Manuals
  • New Drug Applications (NDA)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Policies and Procedures Manuals
  • Preclinical Study Reports
  • Presentations
  • Production Monitoring Plans and Reports
  • Risk Assessments
  • Standard Operating Procedures (SOP)
  • System Functionality Tests and Scripts
  • Test Plans
  • Test Scripts
  • Traceability Matrixes (TM)
  • Training Plans
  • User Requirements Specifications (URS)
  • Validation Master Plans (VMP)
  • Validation Summary Reports (VSR)
  • Verification Plans and Reports
  • Work Instructions
  • Work Practices