Qualtech Consulting Corporation Pty Ltd
Qualtech Consulting Corporation offers expert regulatory consulting and clinical trial services for medical devices, specializing in market access and product registration across Asia and globally. With over 20 years of experience, they provide one-stop solutions for over 1,000 clients.
Founded in 2000, Qualtech Consulting Corporation is a leading regulatory consulting and clinical trial (CRO) company for medical devices. With over 20 years of experience and a global network, Qualtech specializes in helping medical device manufacturers gain market access, navigate product registration, and manage post-market activities. They offer comprehensive one-stop solutions, leveraging a cross-disciplinary team of professionals dedicated to integrity, diversity, and continuous learning. Qualtech has successfully assisted over 1,000 clients in achieving market access in various regions and has managed over 5,000 medical device licenses with precision. Their expertise includes Clinical Evaluation Report (CER) writing, crucial for entering markets like the EU and China. They are also adept at navigating specific regional regulations, such as updates from the Thai FDA and Malaysian MDA. With local representation in 12 markets worldwide, including China, Japan, Singapore, Malaysia, Philippines, Hong Kong, Indonesia, and Vietnam, Qualtech provides real-time services and support. They are committed to offering professional assistance without delay, assigning dedicated account managers backed by a strong tech center to ensure an efficient and enjoyable client journey. Their services encompass product registration, clinical services, and authorized representation, making them a trusted partner for medical device companies seeking to expand their business globally.
About
**Who they are**
Qualtech Consulting Corporation Pty Ltd is a regulatory consulting firm with over 20 years of experience, specializing in market access and product registration for medical devices. They offer comprehensive solutions for clients seeking to navigate global regulatory landscapes.
**Expertise & scope**
* Expert regulatory consulting for medical devices.
* Clinical trial services.
* Specialization in market access and product registration.
* Global market access, with a focus on Asia.
* One-stop solutions for regulatory needs.
**Reputation / proof points**
* Over 20 years of experience.
* Served over 1,000 clients.
Qualtech Consulting Corporation Pty Ltd is a regulatory consulting firm with over 20 years of experience, specializing in market access and product registration for medical devices. They offer comprehensive solutions for clients seeking to navigate global regulatory landscapes.
**Expertise & scope**
* Expert regulatory consulting for medical devices.
* Clinical trial services.
* Specialization in market access and product registration.
* Global market access, with a focus on Asia.
* One-stop solutions for regulatory needs.
**Reputation / proof points**
* Over 20 years of experience.
* Served over 1,000 clients.
Additional information
Qualtech Consulting Corporation Pty Ltd focuses on providing end-to-end regulatory support for medical devices. Their services are designed to streamline the process of bringing products to market, particularly in complex regions like Asia. Clients can expect tailored strategies that address specific product types and target markets, aiming for efficient registration and market entry. The firm emphasizes a collaborative approach, working closely with clients to ensure compliance and successful product launches.
Key Highlights
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Founded in 2000, offering over 20 years of experience in medical device regulatory consulting.
Source
“Founded in 2000, Qualtech Consulting Corporation has been providing medical device manufacturers with high quality services”
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Helped over 1,000 companies enter Asian markets.
Source
“We have over 20 years experience on medical device registration and helped more than 1,000 companies entering Asian markets.”
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First company to pass clinical inspection of GCP medical materials by Taiwan Ministry of Health and Welfare.
Source
“We are the 1st company to carry out and pass the clinical inspection of GCP medical materials by the Taiwan Ministry of Health and Welfare.”
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Operates locally through subsidiaries in serviced countries.
Source
“Qualtech Operates Locally through our Subsidiaries in Every Serviced Country.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device companies seeking TGA registration in Australia.
- Companies needing assistance with market access in Asia.
- Businesses requiring end-to-end regulatory consulting.
How engagement typically works
- Project-based consulting.
- Retainer for ongoing regulatory support.
- Collaborative strategy development.
Typical deliverables
- TGA registration submissions.
- Market access strategy reports.
- Clinical trial support documentation.
- Regulatory compliance plans.
Good to know
- Best when clients have a clear understanding of their device classification.
- Requires timely provision of technical and clinical data from the client.
HQ:
Taipei, Taiwan
Languages:
English, Korean, Japanese, Chinese
Timezones:
Australia/Sydney
Claim status:
Listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Hospital equipment, Consumables, Medical devices
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
AUD 8,000
Included services:
Annual ARTG charge reminders and continuity planning, Post-market vigilance support and incident reporting workflow, ARTG inclusion application preparation and submission, TGA device classification and grouping
Evidence Review:
Yes
Supports Artg:
Yes
Australian Entity State:
AU
Additional tga_sponsor_au Details
Supports Artg
Yes
Recall Vigilance Support
true
Australian Entity State
AU
