Obtaining approval to
market a new drug is an expensive, complex, and lengthy process. A critical
element of this process is the medical writing needed to meet regulatory
As a senior medical writer in the pharmaceutical industry for many years, I
know that careful planning, proper organization and formatting, fulfillment
of regulatory requirements, and attention to detail will ensure that your
message is presented clearly and powerfully. Well-designed, insightfully
written documents help to minimize regulatory agency review time, thus
accelerating the time to market.
Throughout my career I have worked with challenging time lines to get the
job done. I thoroughly comprehend the complex problems associated with
preparation of regulatory submissions, and can provide quality, rapid
turn-around for your clinical writing projects.
I hope you will entrust me, and ClinDoc Associates, Ltd., to provide these
services for you. If chosen, I will use the wealth of knowledge and
experience I have gained working on numerous submissions, across
wide-ranging therapeutic areas, to provide your group with quality
documentation delivered on time and on budget!
ClinDoc Associates, Ltd.