Regulatory Affairs Consulting
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Regulatory Affairs consulting - Borderline Products

your fast track to market

Our experienced team can help you with a variety of borderline products

Many products within the healthcare market fall into a ‘grey’ area known as 'borderline products'. This means they're neither a ‘medicine, medical device, cosmetic, herbal, biocide, food, dietary supplement, or general sales product’.

Our team has experience working with a wide variety of borderline products. Whether your product is unique or an innovation to an existing concept, we offer a confidential review service and can provide strategic advice on regulatory classification, legal requirements, and identify the best routes to market.

If necessary, we can also prepare a briefing document to provide to Health Authority, for pre-registration discussion. PDS can also help you with any further development of the product that is needed.