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Preparing Effective Regulatory Documents
Preparing effective regulatory documentation helps to promote:
- More rapid product development
- Less expensive product development
- Speedier FDA approval of products
- Better product labeling
- More efficient communications with FDA
- Savings in staff time and effort during product development
Our customized programs can teach you to:
- Prepare complete and compliant regulatory submissions, including the Common Technical Document
- Describe the essential components of INDs, NDAs (including the Common Technical Document), and other regulatory submissions
- Identify and describe the facets of good and poor writing
- Write clearly and effectively using good sentence, paragraph, and document structure
- Consider your target audience(s)
- Review others’ work and provide constructive comments
- Manage the writing and review process from a project management point of view
- Manage multi-authored documents
- Design and write data-driven and non data-driven (e.g., planning) documents
- Describe the purpose of the regulatory documents created during the pharmaceutical and biotechnology development processes
- Other skills and topics as needed
We can also provide additional services such as:
- Pre-course “needs assessments” to identify the training and development needs of your organization or group
- Pre- or post-course consulting to address specific situations with your group or organization
- Follow-up interviews or assessments
- Summary reports of any assessments performed
Additional formats:
- We offer a number of different formats for customization of this topic, including abbreviated (e.g., half-day) and extended (e.g., two-day) formats, and shorter speeches and keynotes.
Please contact us to discuss how we could create a program to meet your needs.
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