All veterinary medicines, agricultural chemicals and home and garden pesticides must be registered with the APVMA (Australian Pesticides and Veterinary Medicines Authority, www.apvma.gov.au) before they can be marketed in Australia.
The regulatory requirements are becoming increasingly stringent. Our extensive technical expertise and comprehensive understanding of APVMA requirements, enables us to review your data, prepare regulatory strategy and successfully present it to the regulatory authorities to help your company gain and maintain registrations.
Regnvet’s expert regulatory services are:
·Faster, accurate and convenient if in-house regulatory expertise is not available
·Quality services which reduces the registration time frames and in turn helps to introduce the products in market place quicker
Regnvet provides following services:
Dossier preparation for registration of:
·new veterinary product
·new active constituent
·minor/major formulation changes
·new chemical product which is similar/closely similar to a registered product
·repack of a registered chemical product
·extension of use
Product labels:
·preparation of draft labels (text labels, printer proof labels and market printed labels according to the new guidelines)
·variation to a registered chemical product or approved label
·technical label change
·label update
·extension of shelf-life
Permit application:
·minor use permit
·emergency use permit
·field trial/research permit
·permit to possess or supply for export
·AQIS Import permit application
Other:
·Alteration and modification of the international registration dossier to conform to the local format.
·Reviewing the data before APVMA submission for its completeness
·Assessment of a trial protocol
·Act as an approved person to liaise with regulatory authorities and other related agencies on behalf of your organisation
·Technical writing/ literature review to support the registration application
RegnVet offers technical advice on product development programs and registration requirements for veterinary chemicals. Regnvet has the expertise to guide you through various steps to convert an idea to a registered product and a successful product launch in lesser time frame.
We offer following services:
·Monitoring of animal trials on behalf of your company for the whole trial or only critical time-points e.g. treatment day, slaughter day.
·Investigating the field efficacy studies
·Technical advice on trial programs and trial design
·Developing trial protocols and report writing
·Co-ordinate and supervise the laboratory and field trials for product registration in Australia
·Co-ordination and design stability trial for new veterinary chemicals or existing products to extend the shelf-life
·Source the competent formulation or analytical laboratories to undertake product development
