Regulatory Risk Assessment Services
Ignoring emerging regulatory risks could mean delays, extra costs, lost revenue and missed opportunities for your business.
- What happens to your carefully planned business strategy when, before you get to market, Congress changes the law, the FDA writes a new regulation, a program budget you counted on for revenue is slashed — and you never saw it coming?
- Legislative, regulatory, and political changes over the next 12 to 24 months will affect your valuation, your revenue predictions, your capital needs, your timeline for entering the market, and your pricing strategy.
- We make an assessment specifically for your business strategy. Much can change in the heavily regulated healthcare sector between now and the time a med tech company gets its IP, FDA approval, business partners and investments, licensing and permits and is finally ready to go to market.
- Our Regulatory Risk Assessment gives you a much clearer picture of emerging federal regulatory hurdles — and new opportunities. We make an assessment specifically for your business strategy.
- A Regulatory Risk Assessment identifies your regulatory risk exposure. It develops risk mitigation strategies. It’s designed specifically for your business and your timing.
- A Regulatory Risk Assessment saves you time and money by avoiding regulatory delays and extra costs. Customization not only reduces your risk exposure, it increases your revenue through a sound strategy.
Regulatory Risk Assessment Advantage
- Designed for your specific business or investment strategy
- Identifies emerging regulatory risks and opportunities
- Saves you time, money and resources; gives third party validation
- Forward-looking research and analysis
- Incorporates human intelligence
- Applied know-how by experienced Washington health policy experts
- Risk mitigation
- Scaled to meet your needs
Coming to a regulated sector near you: New risks
- Mobile health app uChek failed to see new regulatory risk as the FDA stepped up scrutiny of mHealth as medical devices. The start-up had only a third of the funds needed to jump this regulatory hurdle, so it’s not in the U.S. market.
- In 2013 alone, HHS, CMS, and FDA added $16 billion in extra regulatory costs and 25.7 million hours of new paperwork requirements to health sector companies.
- Pharma and medical device firms face $200,000 for Sunshine Act compliance; HIPAA privacy and security rules now cost the hospital sector $8.2 billion a year.
Don’t hope or guess; assess
You might garner hints of some of the regulatory changes in the works from trade publications, webinars, seminars, white papers, etc. But they amount to general information, not specific to and analyzed with your business strategy in mind.
- The Regulatory Risk Assessment (RA) incorporates human intelligence, legislative and policy research, analysis, and insights from our own insider experience in Congress and the administrative branch and our understanding of how Washington works.
- Our RA enables you to anticipate the coming regulatory threats, vulnerabilities, and opportunities not readily recognized that you face and to understand how they’ll affect your business or investment. The RA examines these for your time horizon.
Peace of Mind
Our Regulatory Risk Assessment improves your business strategy and gives you peace of mind.
You could join a trade association or chat up an expert at a conference. But that, too, will be general or less comprehensive than you really need to be actionable.
A better option is a customized regulatory risk assessment and mitigation strategy.