Regulatory Affairs

The law is what is read, not what is written.

Donald Kingsbury – Author

Regulatory affairs are an aspect of the chemical industry that cannot be overseen in day to day operations. Companies have to comply with many laws and regulations on a local, national and European level. Regulatory affairs are changing at a fast pace and it can be quite a task to keep up, both for companies and government agencies.

It can be challenging to determine which regulations apply to a specific product or process. In addition, customers of chemical companies often have many regulatory requests related to their application of a chemical product which need to be answered before an order can be placed. Not every company has the possibility to internally hire a regulatory affairs specialist for their products and processes. A legal consultant is well aware of the laws and regulations, but often lacks the substantial knowledge to adequately estimate the consequences for a specific properties.

Techem Consultancy fills the gap for its customers between the general laws and regulations and the specific substantial situation for their products and processes. We help interpret the laws and regulations for existing and new products in order to fulfil the regulatory demands by customers and authorities. If a legal guarantee is then still required, less hours (at usually a high rate) from a legal consultant will be required.

Specific services:

• Writing individual regulatory statements on products for customers
• Setting up a documentation system for regulatory statement on products for customers
• Investigation of specific regulations and their applicability on products and processes
• Defining boundaries as a result of regulations in the early stages of new product development

If you are interested in one of the aforementioned services or if you have a question, please feel free to contact us without any obligations via our Contact page.