Regulatory affairs

The regulatory affairs service, helps clients register or extend their products. Staphyt has considerable experience in the conduct of efficacy, residue and crop safety trials for companies requiring data for registration submissions.

Staphyt has the skills and resources to work closely with the authorities, developing successful submissions to the APVMA or the New Zealand authorities, EPA and ACVM. The industry is changing, with leading edge technology and innovation being key components of new products.

This calls for unusual regulatory skills alongside the traditional:

  • Innovative, regulatory and novel technology strategies
  • Product registration with the APVMA, EPA and ACVM
  • Pre-Application Assistance including data GAP analysis, registration strategies, time-shift applications, fee/time waiver negotiation
  • Dossier preparation – Chemistry and Manufacture, Toxicology, Metabolism and Kinetics, Residues, Occupational Health and Safety, Environment, Efficacy and Crop Safety
  • Active ingredient approval
  • Label extensions and formulation changes
  • Minor-use permits
  • Compliance checks for marketing material
  • Literature reviews and technical writing

Staphyt can help its clients win on cost and efficiency by managing the entire project, from development of the trial program to registration.
Staphyt Regulatory division can assist with registrations in Europe, Australia and New Zealand.

For all regulatory assistance enquiries, please contact Melita Shalders on +61 409 841
692 or mshalders@staphyt.com.

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