About Us

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About Us

Protocol Writers is a trade name of TMAP Solutions LLC – a validation consultancy company based in California that was established in 2017. Protocol Writers was created in response to the need for writing various QMS-documents, and is committed to delivering comprehensive drafts to clients within 24 hours and complete protocols within a week.

We Write Quality

Protocol Writers operates with a need-oriented approach to help clients with their requests. They create customized, quality documents by understanding  the clients’ needs, resources, and capabilities and using their experience from working with the biggest biopharmaceutical companies such as:

  • Genentech

  • Novartis

  • Bayer

  • and many more.

This is backed up by up-to-date knowledge on standards released by these regulatory agencies:

  • Food and Drug Administration (FDA)

  • International Standards Organization (ISO)

  • European Commission – EudraLex,

  • World Health Organization (WHO)

Tap From Our Expertise

The company is composed of experts who mastered the FDA Lifecycle Approach by studying the major validation principles and standards recommended in the FDA Guidances for Industry. This helps Protocol Writers provide its clients with the best strategy to avoid non-compliance from FDA inspection citations.

Projects

Protocol Writers believes it can deliver validation protocols faster. That is the idea behind QualPrime Author – a software-as-a-service (SaaS) which allows users to generate validation protocols in just minutes.

Our Vision

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

Click here for more information about Protocol Writers.