Technical and regulatory support for biopesticide ingredient approval.
Although biocontrol agents are widely regarded as "safer" to humans and the environment, gaining approval to implement them presents a number of technical and regulatory challenges, not the least of which are characterizing the active substance, explaining its modes of action, and generating a relevant data package to support application for regulatory approval. Ä¢¹½tv's Chemical Regulation & Food Safety team has extensive experience gained as consultants and from previous working experience in the crop protection industry and alongside regulatory authorities and contract research organizations. Our vast experience has given us an excellent mix of skills and perspectives to deliver insights and services, including regulatory strategy, technical challenges, and dossier preparation.
Services
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• Development of regulatory strategy and technical assistance, including data gap analyses, preliminary and higher tier risk assessments, and regulatory scoping
• Placement and monitoring studies needed to support product registration
• Regulatory dossier preparation for national, EU, or global submissions including study summaries, risk assessments, regulatory overviews, and position documents
• Classification and labeling support, including the preparation of submissions on harmonized classification and labeling
• Preparation of efficacy and/or biological dossiers in appropriate formats
• Preparation of literature reviews in line with EU requirements using our internal library services
• Pre-submission support for communications with regulatory authorities at EU member state level, the EU Commission, EFSA, and ECHA
• Post-submission support and liaising with regulatory authorities to help clients navigate the regulatory process through to conclusion
• Task force management
• Production and submission of dossiers in electronic formats, such as IUCLID and CADDY
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Food
Food safety, nutrition, and dietary exposure assessments, and technical and regulatory support.
Biocides & Antimicrobials
Expertise in multifaceted regulatory requirements in biocide and antimicrobial product approval processes.
Agrochemicals & Pesticides
Navigate complex requirements for agrochemicals and pesticides in Europe and North America.
Consumer Products: Cosmetics & Personal Care
Personal care products consulting for registration, notification targets, and product development.
Industrial Chemicals
Regulatory support for chemicals, solvents, polymers, antimicrobials, biocides, and more.
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.
Practice Director and Principal Scientist