- Strategic regulatory consultation
- Due diligence: product and company acquisition
- FDA meetings-strategy, briefing packages, conduct of meetings and negotiations
- Regulatory Gap Analyses
- Promotion and Advertising-regulatory strategy/opinion/review of launch
and post-launch materials, ongoing copy review services
- Drug, device, and combination product development
of regulations, guidelines, position papers
- Health Care Compliance-HCC program construction based on OIG framework, sales training programs
- IND/NDA and Device- planning/preparation/review services
- Retainer services for ad hoc regulatory Q&A
- Regulatory Training
Please contact us if you do not see a specific service that meets your needs.
We may be able to accommodate your project.