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Cynthia M. Davis, Ph.D., President |
Medical
Writing Services |
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Phone: (919) 303-9798 FAX: (919) 303-9859 Email: cindy at
davismedwrite.com Site Index: |
The drug development
process is long and complex, and ultimately, the products are the documents
that are submitted to international regulatory authorities to obtain approval.
Unfortunately, the writing of the clinical documents is often the most
time-pressured phase in the preparation for submission. As a pharmaceutical
industry-experienced senior medical writer, I have an understanding of the
time constraints and pressures to "get it right the first time" and
I will strive to meet customer needs for reviewer-friendly documents leading
to swift regulatory approvals and earlier product launches. During my career as a senior
medical writer, I wrote at least 80 different Clinical Submission Documents
in support of over 12 different NDA and/or MAA Regulatory Submissions.
Meeting accelerated timelines with quality documents was frequently a factor
in these submissions. Since being in business
since January 2001, Davis Medical Writing, Inc. has worked with several
different pharmaceutical companies to prepare documents for numerous
Regulatory Submissions. As a contract medical writer, I will apply my
experience to your documents to help you meet timelines with quality
documents that will ultimately lead to swift approval for your medicine. |