Challenges

Many countries or regions require you to notify any new substance before it is manufactured or “placed on the market” for the first time. The regulatory authorities have similar but slightly different requirements for each region. Some of the main regions or countries with notification requirements are: USA, European Union, Canada, Japan, Australia and most recently, China.

Global companies are trying to reach global markets – it’s just as important to minimize costs as to maximize the speed to market. So it is essential to plan ahead.

Solutions

With our global network of experts and close contacts with regulatory authorities around the world, we can help you:

  • Define the regulatory strategy to fit with your marketing plans
  • Review suitability of the toxicology studies you already have
  • Agree costs and commission necessary toxicology testing to fill data gaps
  • Prepare and submit regulatory dossier to authorities
  • Liaise with the authorities to obtain approval for you