Regulatory Affairs Australia
Eurofins Agroscience Services provides a full range of consulting and regulatory services leading to the compilation of registration documentation for agricultural pesticides and veterinary medicines for the Australian (APVMA) and New Zealand (ACVM and EPA) regulatory bodies. We have a wealth of experience covering all disciplines of active ingredient and product registration dossier submissions. We also have Qualified Persons on staff to prepare Plant Breeders Rights (PBR) applications including descriptions.
With strength in depth, our highly experienced team of experts can cover all aspects of your registration portfolio.
Eurofins Agroscience Services offer a 'one stop shop' tailored service including management of multi-site and multi-disciplinary projects; a combination of in-house testing and, where necessary, sub-contracted phases are supported by specialist project management and dedicated logistics.
As a national service provider and market leader, Eurofins Agroscience Services can promise unparalleled expertise and a commitment to excellence. We can fully support large development projects as well as local regulatory projects, including single data dossier preparation.
You can expect:
- Provision of sound regulatory advice and strategy
- Project Management for all or part of your testing programmes
- Scientific experts with specialised areas of expertise
- A "one stop shop" for all aspects of registration
We offer full consulting services which include:
- Advice on data requirements
- Review of protocols in order to guarantee compliance with all relevant guidelines
- Cost-effective strategies to support proposed product registration criteria
- Peer review/critical gap analysis of existing data sets
Regulatory services include:
- Chemistry and Manufacture
- Metabolism and Kinetics
- Occupational Health and Safety
- Efficacy and Safety
- We can act as nominated agent for overseas product registration holders