Regulatory Services

i2LResearch can assist clients in obtaining and maintaining product registrations through our global consultant network.

Europe

Collaboration with Barkwith Associates, Lincolnshire, UK, offering data gap analysis, study management and dossier preparation and submission both for biocides and plant protection products/biopesticides.


Collaboration with Entotek Bio Consulting Ltd., Winchester, UK. Entotek BC provides expert support and advice with development and registration of low-risk biopesticides, and novel semiochemical products in crop protection and professional pest control.

North America

Strategic collaboration with SciReg, Inc., Washington, DC area, USA, offering scientific, regulatory, and quality assurance support for companies seeking to obtain and maintain registrations with EPA and all 50 states.

Australia

Collaboration with Competitive Advantage Consultants in Sydney, Australia, offering regulatory services and efficacy testing support for Australasia.

China

Collaboration with CIRS in Hangzhou, China.

South America

Collaboration with Vigna Brasil, Brazil

Regulatory services offered include:

Data gap analysis:

  • Assessment of existing study package and identification of further requirements for completed dossier/submission presentation.

Study management:

  • Regulatory testing strategies and study design (GLP/GEP)
  • Study monitoring
  • Preparation of study summaries

Dossier/submission preparation and regulatory affairs:

  • Registration applications and maintenance
  • Label amendments
  • Technical equivalents
  • Representation with regulatory authorities