What is Regulatory Writing?
Regulatory or Medical Writing is the activity to develop regulatory documents that are required to be submitted to Federal Agencies.
The activity of developing regulatory documents is performed by Medical Writer. Principal Investigators, other site personnel, statisticians, regulatory professionals should work hand in hand with Medical Writer to produce documents that meet all applicable regulatory requirements and of high quality.
Some examples of documents that require medical writers are
- Clinical Trial Protocols
- Investigational New Drug Applications (IND)
- Investigators Brochure (IB)
- New Drug Applications (NDA)
- Clinical Study Reports (CSR)
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