Almost every region of the world has a legal framework and statutory body that regulates the manufacture, importation or marketing of chemicals. Many regulatory endpoints are based on harmonized testing methodologies although their application can be subtly different across regulators. In addition, the interpretation and usage of the resulting data can vary. A good example of this is the comparison between the regulatory approaches of the EU/ECHA and the US/EPA. EU REACH is a hazard based system, while TSCA is a risk based system. The data and regulatory arguments supporting the same chemical in both jurisdictions therefore require different tactics.
Navigating your chemical onto the global market can therefore be challenging. You need a broad and deep understanding of different regulations and strategic insight to help you leverage your data in the most efficient and cost-effective manner. You also need to ensure that your chemical’s regulatory journey to approval is as rapid and smooth as possible. That means anticipating regulatory hurdles and having clear mitigation plans from the start.
As your partner, we can guide and support you and your chemical through the regulatory journey, for any regulator, anywhere in the world. Our team has wide ranging regulatory, scientific and business expertise gained from industry, regulatory agencies, consultancies and research institutes.
By intimately combining strategy, regulatory science and operational execution we have repeatedly delivered the regulatory objectives of our clients in a timely and cost-effective way. Our strength lies in problem-solving and joined-up thinking, so you can be confident your chemical is in safe and experienced hands.