Provide Product Registration, Clinical Trials, Local Agent and Regulatory Research Services.

Qualtech Consulting Corporation was founded in 2000 by Dr. Chang Yin Pen. It is a regulatory consulting service and clinical trial (CRO) company for medical devices in Asia. Since its inception, Qaultech has operated a cross-disciplinary team of professionals with integrity, diversity, continuous learning, and teamwork, and provides clients with quality, efficiency and one-stop legal consulting and clinical trial services.
We have created a number of high-quality products that have successfully entered emerging markets in Asia through our strong partnership with each customer, and have built a reputation for providing regulatory advice quality and efficiency.

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[ANALYSIS] ASEAN Demands and Market Opportunities for Cosmetic Implants and Procedures – May, 2020

Qualtech Your best choice

Qualtech | 理工科技
Medical Device Registration

Having 20 years of regulatory registration experience, we offer product registration services in 10 Asian countries. Moreover, we set up the sales center in Japan, United State and Europe to provide direct customer service.

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Qualtech | 理工科技
Clinical Trials

We provide a full range of services including clinical trials, clinical evaluation reports and post-marketing clinical follow-up. We are the first company to implement and pass the GCP by Taiwan FDA. We have also passed many GCP in China.

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Qualtech | 理工科技
Local agent

We can act as a local product license manager at the manufacturing facility. Help you with such activities as regulations and post-marketing tracking, and provide immediate regulatory updates.

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Qualtech Solution

Multi-country Submission

Multi-country Submission

Qualtech provides you with multi-country registration solutions. What you need to do is only to contact a single window and prepare a set of documents.

One-Stop Registration

One-Stop Registration

Qualtech conducts clinical trials based on registered experience, which meets the needs of local health authorities; We are familiar with clinical trial requirements in the Asian market.

Market Access Strategy

Market Access Strategy

Qualtech can provide you with multi-regional regulatory research, market research, product standard assessment and competitive product search services

Qualtech | 理工科技