Biopesticides & BioControl Agents

Crop protection products based on active substances of natural origin such as plant extracts or microbial organisms are becoming increasingly mainstream. They are used either as the primary means of pest control or alongside conventional chemical products as part of a holistic integrated crop management strategies. Although biocontrol agents are widely regarded as being safer to humans and to the environment, achieving product registration can present its own technical and regulatory challenges, not least defining the active substance and explaining modes of action. Exponent has the collective expertise to help our clients address these challenges.

Exponent’s considerable team has extensive experience gained both as consultants and from previous working experience in the crop protection industry, regulatory authorities and Contract Research Organisations.  This gives us an excellent mix of skills and perspectives to deliver advice and services on regulatory strategy, technical challenges and dossier preparation.

Services

Exponent can provide a complete and tailored service to support the registration of bio-control agents, including:

  • Development of regulatory strategy and technical assistance including data gap analyses, preliminary and higher tier risk assessments and submission scoping;
  • Placing 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 labelling support including the preparation of submissions on harmonised classification and labelling;
  • Preparation of efficacy / biological dossiers in appropriate formats;
  • Preparation of literature reviews in line with EU requirements using our internal Library Services;
  • Pre-submission support when dealing with regulatory authorities at EU member state level, the EU Commission, EFSA and ECHA;
  • Post-submission support and liaison with regulatory authorities to help clients to navigate the regulatory process through to conclusion;
  • Task Force management;
  • Production and submission of dossiers in electronic formats such as CADDY and IUCLID.

Professionals