Agrochemical Regulatory Affairs & Compliance Services Provider : GPC Regulatory

End-to-End Agrochemical Regulatory Strategy & Consultancy

Reaching commercialization of agrochemicals worldwide is highly intricate as it requires regulatory approvals from various Government bodies and statutory bodies at the Central and State levels, primarily the Central Insecticides Board & Registration Committee (CIB&RC). As a seasoned agrochemical consultant company, we assist clients in the strategic planning and regulatory approval for the commercialization of their product. We carry out a regulatory gap analysis to identify missing data or any content that is required to complete the submissions. We also provide strategic direction to the client on the required regulatory roadmap and provide an estimated timeline to regulatory approval. We are also well versed with the requirements of the Insecticides Act, 1968 and the rules made there under.

 Agrochemical Dossier Preparation & Submission Management

A robust technical dossier is critical to obtain regulatory approval for any agrochemical product or ingredient. Our agrochemical regulatory consultant team at Clarity creates solid dossiers that are scientifically valid and meet regulatory requirements. Toxicology, residue, and bio-efficacy studies are compiled into dossiers and submitted to relevant bodies in China. All dossiers are formatted in accordance with the CIB&RC requirements and submitted online through the CIB&RC portal.

Agrochemical Study Management & Laboratory Support

Having accurate and high-quality data is paramount to achieve approvals for regulatory bodies. As your agrochemical consultant, we can advise on the data required for a product and ensure that study data are generated and reported to the necessary quality standards. We work closely with GLP certified laboratories to conduct residue and toxicology studies, and also ensure the studies are compliant with local and international guidelines. We can also assist in the design and management of field trials to ensure they are conducted in accordance with relevant regulations to generate robust data.

Agrochemical Product Registration & Licensing Support

All aspects of agrochemical product registration are handled by our staff of experts. As an agrochemical regulatory company, we can assist in the registration of pesticides as well as other plant protection products. Registration for bio-pesticides and biostimulants is also offered by us, as the highly regulated nature of these products often requires specialized knowledge. In addition, we assist in obtaining import/export licensing and provide advice on labeling and packaging that is in compliance with India’s pesticide laws.

Post-Approval Agrochemical Compliance & Lifecycle Management

Our agrochemical regulatory service doesn’t end at approval. We can assist with the renewal, modification or extension of the registration of existing products, and provide ongoing regulatory support for reporting and maintenance. We are always tracking any updates to regulatory requirements that could affect your portfolio and can provide early warning and advice as necessary.