SynTech Research » What we do » Program management / Regulatory

Program management / Regulatory

Syntech Research, dossier preparation

Dossier preparation

SynTech Research is a global Contract Research Organization, including seasoned professionals with long experience in the research and development of crop protection products.  The company delivers high quality field and laboratory studies to determine the safety and efficacy of new agrochemicals and crop varieties, adding value and competitive advantage to clients through its in-depth knowledge of the crop protection industry and its products.  For over 10 years, SynTech Research has developed a reputation as a leading provider of programs at country, regional and global level to over 200 client companies worldwide.

A full management service menu is provided to organizations wishing to develop plant protection products, from new chemical entities or formulations, to additional territory or crop registrations. It offers a range of multi-discipline and cross-site services to enable customers to plan, manage and deliver all – or elements – of a project,  to completion including:

  • Planning of programs and input to protocols to meet technical and commercial objectives, including determination of studies required for biological assessment dossiers
  • Study Direction and Monitoring at country, regional and global level
  • Laboratory and field characterization of product performance (GEP), environmental fate and ecotoxicology (GLP), using the network of 26 field stations and partner analytical laboratories
  • Reporting in standard and customer-designed formats
  • Expert assembly of data and preparation of biological assessment dossiers
  • Regulatory submissions to USA-EPA, PMRA, EU, Asia and Latin American authorities by SynTech Research or with partner organizations

SynTech Research has experienced project managers with scientific and technical skills, who work closely with its customers to define objectives, associated trials plans and timelines for completion and reporting, aiming at maximum speed and cost-effectiveness. They will manage delivery of projects, combining in-house and sub-contracted phases, from the wider SynTech Research organization and its partnerships.

To download a copy of the Program management and regulatory services flier click here