Experienced guidance for new chemical introductions
With more than 30 offices and over 1,000 staff worldwide, Ä¢¹½tv has provided services to the chemical industry for nearly 50 years. Our experts in the U.K., EU, U.S., and Asia offer a wide range of technical and regulatory expertise to help companies of all sizes meet their new chemical regulatory obligations worldwide. Ä¢¹½tv's large industrial chemical notifications team includes regulatory affairs professionals, project managers, risk assessors, and technical specialists in all relevant scientific disciplines, who can help you achieve the successful registration of a product. These scientists have varying backgrounds in industry, government, and contract research, which positions Ä¢¹½tv to offer unparalleled expertise and insights related to complex regulatory challenges.
Many of our consulting staff have been working in the field of chemical regulations for more than 10 years and have extensive experience with a variety of global chemical regulatory schemes. Our team has extensive knowledge and resources related to chemical regulatory systems, including a network of local agents who can translate documents into native language and liaise effectively with regulatory authorities.
Services
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• Regulatory strategy and advice for chemicals and the specific requirements for polymers
• Project management services
• Inventory searches and amendments or additions to inventories
• Bonafide intent to supply submissions including Article 26 inquiry submissions in the EU
• Data evaluation and gap analysis; determination of data availability of data and evaluation of their suitability (Klimisch rating)
• Use of intelligent testing strategies, including grouping and read across, data waivers, expert statements, and (Q)SAR modeling
• Development of harmonized notification strategies and testing programs to meet worldwide requirements for a single product
• Pre-notification consultations with competent authorities
• Dossier preparation and submission for all types of exemptions and notifications at all levels of supply
• Study placement and monitoring, including all studies required for chemical notifications such as "in-country" studies to comply with certain regulatory requirements or preferences
• Risk assessments, including chemical safety reports
• Classification and labeling
• Safety data sheets, including extended safety data sheets
• Post-notification support
• Tracking of emerging issues and developing notification schemes
Experts
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.
