In-house regulatory support now available for AU and NZ !

Did you know that in addition to the conduct of efficacy, residue and crop safety trials for registration, Staphyt Australia now offers in-house regulatory support to our Australian and New Zealand clients?

With the appointment of Melita Shalders in the role of Senior Regulatory Manager, Staphyt can now provide a comprehensive service across all aspects of data generation and registration in Australia and New Zealand.
With over 16 years’ experience in regulatory affairs working for, and with, multinational companies to develop and register new products and label extensions plus a background in field trials, Staphyt can now provide our clients with complete regulatory support from the initial planning stages right through to dossier preparation, submission and post-registration compliance. 

With support from a global scientific team of experts in toxicology, efficacy, residues, chemistry, environment and efficacy, Staphyt has the skills and experience to deliver complete project management and quality registration dossiers that meet the requirements for approval. 

Our regulatory services include:

  • Product registration and renewals with APVMA, EPA and ACVM
  • Active ingredient approval
  • Label extensions and label updates
  • Formulation and manufacturing changes
  • Minor-use permits
  • Pre-Application Assistance including data GAP analysis, data requirement confirmation, registration strategies, review of local/overseas data
  • Liaison with regulatory bodies
  • Dossier preparation – Chemistry and Manufacture, Toxicology, Metabolism and Kinetics, Residues, Occupational Health and Safety, Environment, Efficacy and Safety
  • Trial planning/protocol compliance
  • Co-ordination of external data reviewers for ACVM applications
  • Post-registration activities
  • Compliance checks for marketing material
  • Literature reviews and technical writing

With the addition of regulatory support for our clients and field teams, Staphyt is now your complete registration service provider in ANZ.

For all regulatory assistance enquiries, please contact Melita Shalders on 0409 841 692 or mshalders@staphyt.com.

Melita SHALDERS
Senior Regulatory Manager