Reports Tailored To Meet Your Requirements

We will provide you with world-class reports that summarize the reproductive effects of your company's products. The reports include data from our proprietary databases, public databases worldwide, and the published literature. We author these reports with quality and compliance in mind and in a format that you can share internally and/or externally.

Our Maternal Health experts can also write documents for a variety of audiences, manage writing projects, and maintain consistency of style and message across multiple documents.

Examples of How Our Expert Reports Can Help You:

Risk Management Report

    This report compares your product's potential reproductive risks to those of similar products (eg, drugs in the same class or drugs for the same indication) and provides detailed suggestions for surveillance activities and mitigation strategies. Lactation and effects on fertility are also included.

White Paper to Support Language for Labels

    This report provides scientifically-based justification for the pregnancy, lactation, and effects on fertility sections of your product's labels. If needed, we will also address regional variations. The document is written to be readily submitted to regulatory agencies.

Regulatory reporting
Pregistry offers the following upon identification of an adverse event:

  • Adverse event triage
  • Case management/Assessment of relatedness
  • Event reporting.

Clinical and Observational Study Reports

    Has your company perfomed a clinical or an observational study and you need an expert to write the interim or final report? We have decades of experience doing that! And because we have experts in different fields (eg, clinical, pharmacovigilance, teratology), we can do this timely and with minimal oversight.

Reproductive Risk Report

    This document contains all that is available about your product's reproductive risk, including data from our pregnancy exposure registry, licensed specialized databases, articles published in the medical literature, and the experience of our Maternal Health experts. Lactation and effects on fertility are also included. These reports can be formatted for regulatory use or for internal distribution (we can also create a great PowerPoint presentation for your audience!).

The Pregnancy and Lactation Report

    This most comprehensive report includes all the contents of the other reports: a detailed description of your product, indication, and exposure, a complete review of the literaure, summary results from clinical and observational studies, a description of the identified and potential reproductive risks, surveillance activities, risk mitigation strategies, and the language for various regulatory documents. It's an all-in-one document, which we can update periodically for you.

Contact us now to see how we can help you

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After reading one of Pregistry's reports I realize that they can only be written by dedicated Drug Safety specialists in pregnancy and lactation. They set a very high bar.

B.A., Vicepresident of Patient Safety, San Diego

Contact us now to see how we can help you

Contact us