The Arcadia Business Consulting team are committed to building the reputation, trust and infrastructure of our clients. We strive to bring your products to market in a timely manner, with our experts exploring every avenue for precise market placement.
Our team has extensive local market knowledge and are well-respected in their fields internationally. Our expertise aligns to working with clients from equipment manufacturers (OEMs), health product distributors, Medtech start-ups / scale-up innovators across the entire medical spectrum from medical devices, implantable devices, wearables, consumables, pharmaceuticals and IT software industries.
Allow us to help with your ‘to-market’ strategy, we are confident that we can save you time and money!
As an independent organisation, we offer freelance consultancy with the flexibility of both time and location. We can provide the following types of scalable, independent business support services in a tailored and professional manner, which we divide into four key consulting areas.
Regulatory Consulting Service:
- Support establishing your company as Australian or NZ business entity (local address required)
- Coordinate TGA (Australia) submissions and MEDSAFE (NZ) for all product classifications under local entity
- Technical File development, Clinical Evaluation Reviews (CER) written for the distinct ANZ markets
- Market Access, reimbursement options, insurance insights, clinical experts or early adopter engagement
- Marketing material development and technical medical copy writing specific to the unique ANZ legislation
Regulatory Sponsorship Service:
- TGA (Australia) and MedSafe (NZ) submission services for all products classifications, sponsored by Arcadia
- Arcadia act as local sponsor of behalf of the company (without local entity) requiring TGA / MedSafe listings
- For successfully listed items and sponsored by Arcadia, a monthly Regulatory Retention Fee* is chargeable per month, per sponsored entry in addition to the Regulatory Consulting Service fees.
Commercialisation Consulting Services:
- Market entry strategies and product launch guidance through the lens of our diverse consulting team
- Distributor assessment and introductions, with or without on-going support and country management
- Market research, sales opportunity evaluations, competitor and competitive technology analysis
- Project management consulting, clinical trials proposals, event management and networking
- Procurement / purchasing, inventory and shipping advice
- Independent product evaluations and reviews
Sales & Clinical Applications Services:
- Sales, local business development support and trade-stand booth / conference attendance
- Team mentoring, clinical applications user training and training for ANZ representatives
*Regulatory Retention Fee Services include ISO / DoC / QA assessments, TGA sponsorship, MEDSAFE notifications, ARTG entries submitted / maintained, post-market vigilance, annual renewals assessed, Manufacturer’s corrective actions and recall support.
Clients and Partner Organisations
UK & Ireland medical technology distribution company
Global charity which focuses on teaching key clinical skills to health professionals
Radiology Equipment, Asset Management & Procurement Specialists
Australian-based, novel technology for high-level disinfection of ultrasound probes.
Independent Funeral Industry Support Services - promoting best practice, education and training programmes for the funeral industry
Our specialty is the in following areas; Medtech commercialisation strategy, market entry strategies, medical product launches, early adopter engagement, market access reimbursement regulatory, marketing material development, conferences promoting medical devices, healthcare technology financing, medical device marketing and sales, radiology devices, medical device commercialization and healthcare market research to name a few.