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Pharmaceutical Documentation

We are experts in pharmaceutical-related documentation

We have writers with many years of experience working with pharmaceutical and biopharma companies. We also have Medical Device experience.

Our Medical Writers and scientists can assist you with the following:

    • Backgrounders
    • Patient education material
    • Reports
    • Scientific journal articles

Some of the cGMP Quality Systems documentation we have produced include:

    • Document Management SOPs
    • Engineering Document/Drawing Management SOPs
    • Engineering SOPs
    • Engineering Lifecycle SOPs
    • Environment Management SOPs
    • Facilities SOPs
    • General Policy SOPs
    • Information Technology SOPs
    • Maintenance SOPs
    • Manufacturing SOPs
    • Metrology SOPs
    • Quality Assurance (QA / QE) SOPs
    • Quality Systems SOPs
    • Security SOPs
    • Training SOPs
    • Validation SOPs
    • Validated Computer System SOPs
    • Validated Computer System Lifecycle SOPs

We also have experience developing Commissioning and Qualification (C&Q) Validation Documentation. And, we have developed training materials including CBTs and OJTs supporting the Quality Systems. Our experience extends to Consent Decree documentation remediation for the aforementioned Quality Systems documentation.

Contact us at for a free consultation. Or call 1-800-985-7701. We will show you how to improve your content processes–and increase your productivity.

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