Serving the biotechnology, pharmaceutical, medical device,
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Dr. Susan E. Caldwell, medical writer consultant and president of Biotech Ink, is a veteran medical writer. She advises clients on content, scope, organization, and format of materials for eCTD and other regulatory submissions. At all stages of R & D, she recommends strategies for clear, compelling data presentation data for regulatory submissions. She makes recommendations on document preparation decisions that minimize version control issues and enhance publication readiness. Susan also provides comprehensive document review services to ensure high-quality document work products. Finally, she writes many types of documents, including eCTDs as NDAs, BLAs, sBLAs, INDs, PMAs, white papers, executive summaries, and blogs.
Sometimes, Susan is the only writer on our projects. However, she can assign more writers to projects that have tight deadlines, so that clients still receive a high-quality product. Call us (206-949-1121) for a free consultation!