CARSL
Consulting

We provide in-country representation as your Marketing Authorisation Holder in New Zealand for Pharmaceutical and Medical Device products – Your MedTech Sponsor for New Zealand

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Your Trusted Medsafe Sponsor in New Zealand for 29 Years

At CARSL Consulting, we serve as your dedicated Medsafe Sponsor, providing essential regulatory support for Pharmaceutical & Medical Device companies seeking to enter the New Zealand market. Our services ensure that your products comply with all local regulations, facilitating a smooth and efficient market entry.

Regulatory and Associated Services in New Zealand

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.

Choosing CARSL for your regulatory services

CARSL Consulting provide regulatory and associated services to the pharmaceutical, and related industries. This covers the ethical prescription, generic, OTC, medical device, complementary and dietary supplement industry sectors. In addition to new product applications and listings, and variation applications, we provide other services such as strategic business advice and the implementation of quality systems. We can provide advice in areas such as label and promotional material review for complementary medicines, as well as the listing of product in Australia.

Broad range of Experience

With over 40 years in the pharmaceutical industry, David Smyth and the CARSL team offer unparalleled insight into regulatory pathways. From generics to cutting-edge therapies, we’ve successfully facilitated approvals for a diverse range of products.

Professional and Reliable

Our commitment to confidentiality and professionalism sets us apart. Whether you’re a global pharmaceutical giant or a local healthcare innovator, we deliver results with integrity.

Competitive Rates

We believe world-class regulatory services shouldn’t break the bank. Our tailored solutions provide unbeatable value while ensuring compliance excellence.

Industries We Serve

Medical Devices & Diagnostics

In the ever-evolving world of medical devices and diagnostics, staying ahead of regulatory requirements is critical. CARSL Consulting provides expert guidance to help your products comply with Medsafe and international standards.

Medsafe WAND Notifications: Ensure your devices are registered within 30 days of supply in New Zealand.

Stay prepared for changes under the Ministry of Health (MOH) proposed Medical Products Bill. The Medical Products Bill is intended to replace the Medicines Act 1981, and to provide modern, risk-proportionate regulation of medicines and medical devices

Pharmaceuticals & Biotechnology

Pharmaceutical and biotech companies face a complex web of regulatory requirements, from Clinical Trials to post-market surveillance. At CARSL Consulting, we provide tailored solutions to help your products reach the market efficiently and securely.

Clinical Trial Applications: Navigate New Zealand’s stringent ethical and regulatory frameworks with our expert guidance.
New Medicine Approvals: Ensure timely submissions with accurately prepared applications that meet Medsafe’s standards.
Ongoing Compliance: Stay compliant with regulatory updates, including Changed Medicine Notifications and product variations.

Trust CARSL Consulting to accelerate your pharmaceutical and biotech innovations while ensuring compliance at every stage.

Dietary Supplements

The natural health and wellness industry is booming, and with it comes increasing scrutiny from regulatory bodies. CARSL Consulting helps you position your products confidently in the market while ensuring full compliance.

Labeling & Packaging Reviews: Verify your claims, ingredients, and labels meet New Zealand’s Dietary Supplements Regulations.
Ingredient Compliance: Ensure your formulations align with approved lists for New Zealand and export markets.
International Registration: Simplify the process of listing your supplements in Australia (ARTG) or other global markets.

Let us help your food and supplement products stand out on shelves with the right certifications and approvals.

Dental Devices

We can register your Dental Devices in New Zealand using the same process as Medical devices. Although pre-market approval is not necessary, market entry does require listing your products in Medsafe’s Web Assisted Notification of Devices (WAND) database within 30 days of supply in New Zealand. WAND listing includes the following information:

Risk classification of the device
Manufacturer’s contact information
Global Medical Device Nomenclature (GMDN) Code
Intended purpose of the device

Resources & Updates

Stay informed with the latest updates in the regulatory world. Explore our resource center for articles, case studies, and news tailored to New Zealand's pharmaceutical, medical device, and supplement industries.

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