Services
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.
Prescription & Non-Prescription Medicines
CARSL offers a range of regulatory support which includes assistance in a market access strategy. Our team ensures compliant dossier compilation and submissions in line with Medsafe regulations.
Device Vigilance
We monitor your products performance post market, manage recalls and adverse event reporting, and ensure continued compliance.
Pharmacovigilance
Act as Qualified Person (QP) in dealing with Pharmacovigilance (PV) activities, and as a local contact person to interact with Medsafe. This ensures that adverse events (AEs) and/or adverse drug reactions (ADRs) are promptly and accurately reported according to Medsafe guidelines. We keep a robust system in place to collect and review safety information.
Clinical Trials
Application & Sponsorship. We handle the regulatory documentation and processing as the interface between Medsafe and the Clinical research organisation (CRO).
Quality Management
We can assist with quality system management including audits and SOP preparation.
In-Vitro Diagnostics (IVD’s)
IVDs are categorised as Medical Devices under the Medicines Act 1981. We can provide advice on the regulatory controls as they become apparent to ensure compliance for your in-vitro diagnostics.
Advertising Compliance
We ensure your product labelling, advertising and instructions comply with the Medicine Regulations 1984
Recalls Management
We cover all phases of recall activity that include, Permanent removal of the product from the market, The correction of a problem, & Issuing hazard alerts.