Let’s register your Medicines & Medical Devices
in Australia and New Zealand
In 2013, after many years in the Pharmaceutical and Medical device Industries, Sonja Cuce establish a boutique consulting business in Melbourne, Australia. The philosophy is to work with companies to facilitate the registration and regulatory compliance of Medicines and Medical Devices with Therapeutic Goods Administration (TGA- Australia) and MEDSAFE (New Zealand).
Specialising in tailored regulatory strategies, advice, training, mentoring and support to streamline the registration of Therapeutic Goods for innovator and established companies.
Get in touch with Sonja to set up a consultation, or use the contact form at the bottom of this page to enquire whether I can help you.
Areas of Expertise
Pharmaceuticals
Belsyme Consulting has expert knowledge in the development of regulatory strategy, product registration and life cycle management:
Prescription Medicines,
Generic Medicine
OTC
Regulatory Life cycle MANagement
The initial registration of Therapeutic goods, though a major milestone, is just the being of the regulatory activities. Maintenance of your registrations I can help you with the ongoing Lifecycle maintenance of activities to maintain compliance of your registrations:
Variations,
GMP,
Annual free management,
Transfer of registration
Deletions
MEdicaL Device
The TGA’s Medical Device regulatory framework is risk based approach. TGA allows for expedited assessment for Medical Devices from Comparable overseas regulators (USA FDA, EU MDD, EU MDR, Japan, Health Canada).
Contact me to plan your submission strategy in Australia
Medical devices are currently not required to be registered in New Zealand, however are still required to hold documentation to substantiated conformity of goods. NZ Sponsor are required to notify Medsafe of the supply of goods within 30 days of supply through WAND portal.
Complementary MEDICINES
nutritional SUPPLEMENTS, Vitamins & Herbal Medicines
In New Zealand complementary medicines are currently regulated under the Dietary Supplements Regulations 1985, which fall under the Food Act 1981. Dietary Supplements are presently regulated by Medsafe and therapeutic and marketing claims must comply with the guidelines set out by the Therapeutic Advertising Pre-vetting Services (TAPPS).
MEdicine Shortages
Australia and New Zealand have specific sponsor requirements regarding Medicine shortages. What are your responsibilities?
Are you look at the supplying unregistered goods due to a Medicine shortage in Australia and New Zealand? What is SAS, S19A, S29?
Don’t know where to start…… I do……Give me a call.
Advertising Therapeutic goods in AUSTralia
Advertising direct to the publicly of Prescription Medicines as well as, some OTC’s, complementary and Medical Devices is prohibited in Australia.
Social Media (e.g. Instagram, facebook, twitter), google, websites, blogs, recommendations these are all considered to be “direct to public” advertising.
Contact me and I can help you work through your advertising strategy to ensure compliance.
Regulatory MEntoring, Training and Advice
The registration of Therapeutic Goods in Australia and New Zealand are broad, complex and constantly changing. I can help regulatory teams and small companies navigate the TGA and Medsafe requirements and apply them to specific Therapeutic products. Through specialist training, mentoring and advice options I can tailor options to meet you needs.
“Experience, creative & tailored approach to your regulatory needs”
Let's Chat.
Use the form below to contact Sonja regarding your regulatory needs. Please be as detailed as possible. Include your industry along with any specific project requirements. You may also email or call me to make an appointment.