Regulatory Affairs Management
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We provide a one stop service for managing regulatory approvals for clients importing or working with new plants and animals and new hazardous substances. We provide expertise in:
- hazardous substances and new organisms approvals process, and risk assessment;
- HSNO and Biosecurity compliance;
- quarantine and containment requirements;
- new plant and animals imports, biological control and Biotech regulatory approvals;
- Import Health Standard applications and pest risk assessments
Simplifying the Regulatory Process
Understanding how the regulatory approvals system works is crucial for cost effective access to new plants and animals. Well thought out applications can make the process easier and cheaper, and will save time and money over the long term. The information required to support applications is the single biggest factor impacting on regulatory costs.
Understanding what is important information and what is not can significantly reduce application costs.
Market Access Solutionz can help because we have experience with the process, the information requirements, and all of the regulatory options available. We ensure that:
- the correct applications are submitted, they are of a high standard and they meet the needs of the regulatory agencies;
- applications are prepared that take into account your long term needs; and
- where more than one approval is required (such as for medicines or for an Import Health Standard) all of the necessary applications are completed in an integrated process.
Market Access Solutionz can assist in obtaining all types of new organism approvals, including:
- Importing new plants for commercial release or into containment for research purposes.
- Biotech organisms for field testing or for the production of valuable products, such as biopharmaceuticals.
- Biological control agents for testing and release.
- Importing veterinary and human medicines containing new organisms, such as vaccines.
- Zoo animals and other animals for commercial purposes.
For further information please download this brochure or contact Shaun Slattery.
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