Regulatory Compliance Support and Consulting

Intertek consultants are regulatory and technical professionals with expertise to meet and satisfy customer requirements. Intertek regulatory teams enable the client to find what is right for them. Testing, if required, is carried out at Intertek laboratories, conforming to international and national regulatory standards.

We offer services related to new product introductions, data development, as well as validation of compliance of existing products with local and global regulations. These services are based on our extensive global regulatory knowledge and years of experience dealing with chemicals laws. Through our offices located globally and our established strong network with local as well as regional trade associations and government authorities, we are well-positioned to respond to client needs. Our service offerings cover chemicals, polymers, and end use articles to be commercialized in domestic and international markets.

Regulatory Compliance within European Union (EU)
Chemicals are highly regulated in the EU. For instance, there are currently several dozens of EU directives which apply to industrial chemicals. Moreover, those directives are continuously amended and adapted to the technical progress. Based on our regulatory expertise, we can help our customers to find out the relevant regulatory requirements and to fulfill all their legal obligations.

Key areas of expertise include:

• REACH Regulation compliance
• Expert advice on regulatory aspects of materials and articles for food contact including monomers and additives
• Monitoring FDA , European Union and worldwide regulations for materials and articles in contact with foodstuffs
• Assessing compliance with the regulations
• Preparation of statements and certificates
• Advice on obtaining FDA and EU approval for materials and articles for food contact
• Providing data for and writing petitions to FDA and European Commission
• Determination of overall and specific migration to GLP and UKAS standards
• Medical Device Articles Consulting
• Registration of materials used in potable water applications
• Development of new toxicology and ecotoxicology test methods