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About Us


We, at Protocol Writers, operate with a need-oriented approach to help our clients with their requests. We create customized quality documents by combining our clients’ needs, resources and capabilities and our:

  • the solid experience our staff has built from working with the biggest companies:

    • Genentech

    • Novartis

    • Bayer

    • and many more

  • the up-to-date knowledge on standards released by the

    • International Standards Organization (ISO)

    • European Commission – EudraLex,

    • World Health Organization (WHO)

  • the knowledge from mastering the FDA Lifecycle Approach by studying the major validation principles and standards recommended in the FDA Guidances for Industry

  • the best strategy to avoid non-compliance from FDA inspection citations.

Our aim is to be the game-changer in quality management system compliance. Our service does not stop at writing the document. We are also available for validation consultations if you need guidance in your validation procedures.

Click here for more information about our company.