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Medical and regulatory writing services offered by the BioPharm Team include the following:
- Regulatory submissions, including INDs, NDAs, CTDs, and integrated summaries of safety and efficacy
- Clinical study reports, protocols, investigator brochures, and other documentation
- Information packages and briefing documents for FDA meetings
- Manuscripts, abstracts, monographs, brochures, and other communications (see also publications planning and writing and posters, abstracts, and other medical communications)
- Quality control checks and other document services
BioPharm Team consultants who offer these services:
Cindy Davis, PhD
Fred O. Smith, MD
Chandra Louise, PhD
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