Scope

• Pharmaceuticals / Biologicals
• OTC
• Medical Devices
• Diagnostics

Regulatory Agent

RegAff has companies in several countries, eg USA, EU, Singapore and China, and can act as a regulatory agent.

What does this mean?

A much stronger negotiating position for licensing out by having an a product with marketing approval rather than in the development stage without having a company or resources in a country by use of RegAff’s local company.

As an example, RegAff can provide to US small to medium companies a service to define and negotiate with the SFDA in China the local regulatory clinical development program; create the clinical trial and marketing application dossiers; conduct the clinical trials; and help find companies to license the product post-approval.

For a small US based company, we can, with an early successful EMA Scientific Advice, not only provide you with parallel European development opportunities but in delivering significant regulatory milestones help raise your stock price and facilitate further funding. Similarly, we provide a stronger base for negotiating licenses with Pharma by developing (with our sister company Singeval potentially with their funding) and registering your products eg in China and S. Korea. All such activities have the potential to raise companies stock price and market caps.