Clinical Regulatory Document Writing for Submission.

About Us

At PreciseDox, we write and perform quality control of regulatory documents for Pharmaceutical and Biotechnology companies across multiple therapeutic areas.

For over 20 years, our clients have relied on us to provide the highest quality documents, from dataset interpretation and display to final submissions that meet all regulatory requirements.

Our highly-collaborative group of professionals works closely with you to ensure your documents communicate key messages while our rigorous, quality-control process helps avoid mistakes that can lead to revisions and delays.

As a matter of process, all regulatory documents for submission are created using ICH requirements.

The result: Submission-ready documents that accurately capture key messages for the evaluation of a therapeutic product.

Our mission is to consistently produce precise and timely clinical regulatory documents that assist pharmaceutical and biotechnology organizations with developing new and promising therapies.

INTEGRITY is the guiding principle behind our decision-making process and the work we produce.

We value open and ongoing COMMUNICATION both internally and in our client relationships.

We respect and encourage COLLABORATION within our internal organization as well as with our clients.

We have an unwavering DEDICATION to our clients to produce high-quality documents in line with client timelines.

Our ADAPTABILITY is key to continue providing effective client support in an ever-changing regulatory environment.

As an organization we promise to provide precise and timely documents. Consistently.

To learn more about how we can help your organization or request a quotation, please call us at 610-296-1747.