Regulatory and Drug Development Strategic Consulting
Through our highly experienced team of regulatory affairs consultants, all with strong scientific backgrounds, we can provide regulatory strategy and scientific advice to our clients. Our strategic consulting services encompass a variety of elements such as drug development plans, IND and NDA submission strategy, gap analyses, and conducting Key Opinion Leader panels for your drug program. To learn more about these services, click on the links below:
- Drug Development Plans
- IND and NDA Submissions Strategy
- Gap Analyses and Due Diligence/Licensing Support Activities
- Key Opinion Leader Panels
Our focus is on US clinical and regulatory consulting. However, we do have a network of well-respected and highly experienced nonclinical and CMC expert consultants if you need assistance in these areas, as well. Should your project have a global reach, we can utilize our network of UK/EU regulatory affairs specialists that can provide strategic consulting from a UK/EU perspective and handle any regulatory operations and submissions (eg, IMPD, CTA, MAA, PIPs, Orphan drug applications) for you.
Additional Regulatory and Strategic Consulting Services:
In addition to those activities discussed above, our regulatory affairs consultants can provide clients with a variety of other regulatory and strategic consulting services, as needed. Amongst other things, IMPACT can help clients with:
- Labeling strategy and target product profiles
- Orphan drug strategies
- Accelerating drug development strategies (e.g., Fast Track)
- Risk evaluation and mitigation strategy (REMS)
- General strategic drug development consulting
- Advertising and promotional material review