Medicines & Medical Device Sponsorship
Appointing a New Zealand Sponsor is essential to facilitate the registration process with Medsafe. We provide product stewardship over the lifecycle of the Medicine/Device and ensure compliance with all post marketing vigilance obligations and regulatory file updates with expert and attentive tracking in place.
Entering the New Zealand market can be complex, but CARSL Consulting offers sponsorship services to make it seamless. We specialise in:
- Medsafe Approvals: Guide your products through the approval process efficiently.
- Sponsorship Management: Act as your local representative to simplify compliance.
- Market Expansion Support: Handle requirements for prescription drugs, OTC medicines, and medical devices.
We also provide comprehensive support for:
Medical Device Registrations
Once a device is notified via the Web Assisted Notification of Devices (WAND) database, it can be marketed in New Zealand, provided Medsafe’s regulations are consistently met.
Medicine Registrations
Both prescription and non-prescription medicines require approval by Medsafe before they can be marketed in New Zealand. We manage the compilation and submission of dossiers in line with Medsafe’s regulatory requirements, including:
- New Medicine Applications (NMA): End-to-end support for bringing new medicines to market.
- New Related Product Applications (NRPA): Efficient management of related product approvals.
- Changed Medicine Notifications (CMN): Seamless handling of variations to maintain compliance.
- Self-Assessable Changes (SACN): Manage minor changes to ensure ongoing adherence to regulations.
- Changed Related Product Notifications (CRPN): Support for updates to related product registrations.
Let us be your trusted partner for reliable sponsorship and registration solutions.