Services:   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  strategies Product launch strategy/support Interpretation 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.