Strategic Regulatory Affairs
Other than the tax code, is there any more complex, confusing and shifting set of rules than those governing drug development? Knowledge of regulatory affairs is purely experiential; it can’t be learned in a book. It comes from being at FDA meetings when precedents are set, from unexpected successes, and yes, even from failures. It is the understanding that regulatory affairs is a delicate negotiation requiring that elusive quality called judgment.
- Regulatory strategy
- Clinical support/expertise for Pre-IND, End of Phase 2, Pre-NDA meetings
- Assistance with IND annual reports
- Assistance with Investigator Brochures
- Integrated summaries