Our seven module approach covers all requirements specified by the FDA to ensure that your PMTA includes everything you need.
The Tobacco Products Directive (2014/40/EU) is the European Directive governing the manufacture, importation and sale of tobacco products with the European Union. The Directive covers cigarettes, oral tobacco, novel tobacco products and e-cigarettes & e-liquids (ENDS). The Directive came into legal effect in May 2016.
Since January 2019, CBD products have been regulated as Novel Food Products in the European Union following the decision by the European Commission. CBD manufacturers, trade bodies and suppliers are required to apply for authorisation with a deadline of March 31, 2021 set for all applications for products on the market.
Pharmaceuticals and medical devices are highly regulated with comprehensive requirements to ensure patient safety and product quality and efficacy. Inter Science brings all the required skills together to offer our clients state-of-the-art knowledge to decrease the regulatory burden.