Regulatory affairs & clinical support

Our in-house regulatory affairs team ensures your product is not only ready for market, but compliant with every jurisdiction’s unique rules. We manage the full compliance pathway — from initial market assessment through to submission and approval — so you can enter new markets with confidence.

Whether you’re launching a new product or transferring an existing one to Jaychem for manufacture, we support you in managing the technical, legal, and procedural requirements that get your product approved, registered, and ready for sale.

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We work across prescription and over-the-counter medicines, dietary supplements, nutraceuticals, and personal care products, as well as selected medical devices, with expertise across markets such as NZ, AU, EU, US, Canada, and more.

The Jaychem advantage

Multi-market expertise

Over 100 human and animal medicines successfully registered in NZ, AU, EU, US, Canada, and beyond, including in regulated and emerging markets.

Integrated compliance process

Our regulatory affairs specialists work in tandem with R&D, manufacturing, and quality teams, ensuring all compliance requirements are met from the start.

Proven capability

Recognised by agencies including Medsafe, TGA, ACVM and APVMA, with a strong audit track record and approvals under Mutual Recognition Agreements.

Trusted by global partners

From startups to multinational pharmaceutical companies, our ability to meet stringent compliance standards makes us the go-to partner for complex registrations.

Regulatory support that opens markets

Our specialists combine in-depth market knowledge with a proven track record to get your product approved, and position it for long-term success.

Identifying the classification, standards, and approvals your product will require in each target market.
Defining the most efficient pathway to compliance, balancing cost, timelines, and approval success.
Compiling and lodging complete, compliant dossiers for medicines, medical devices, dietary supplements, and other regulated products.
Reviewing and adapting labels and packaging to meet each market’s language, content, and format rules.
Managing renewals, variations, and post-market requirements to keep your product authorised for sale.
Leveraging our network of international regulatory partners to support product registrations in virtually any market.