Service Introduction

Providing full-process registration consulting services for medical devices and pharmaceuticals

and overseas market launch solutions

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Company Main Business

Focusing on the global healthcare field

Chinese Enterprises

20+

International Enterprises

10+

Business Delivery Rate

100%

Medical Devices & IVD

Registration, Clinical, Quality System Services

Drug Registration

Clinical Services

Registered Product Category

Import Registration

Over 100 types of immunoassay reagents and instruments: Class III, Class II;

Laser products: Class III.

Domestic Registration

Registration of over 200 reagents and instruments: Class II;

Class III infectious disease equipment, PCR reagent class; Class III: software, implantable, active device class 

Domestic drug registration

Chemical drugs Class III, Class IV; Traditional Chinese medicine original Class VI; China, US FDA registration; European, Australian, Japanese registration

Drug overseas registration

According to PIC/S requirements, guide enterprises in drug registration and declaration, GMP on-site inspection: solid dosage forms, injections

13485, CE Certification Guidance

Coagulation, Hematology, Fluorescence, Blood Glucose IVDD, Chemiluminescence, Nucleic Acid, Colloidal Gold IVDD+IVDR

CE Certification Guidance

Biochemistry IVDR: Class C+B;

Glycation IVDR: Class C+B

FDA 510K

COVID-19 reagents;

Blood glucose reagents and instruments;

40 types of reagents, 4 types of instruments

Global Registration

MDSAP Certification

WHO Registration

Global Registration

Southeast Asia Market Registration, Australian TGA Registration, Japan Registration, Middle East Registration, etc.

Overseas market demand - target product orientation

Generic drugsandInnovative drugs

01

Generic drugs with cost advantages and product features;APIs with innovation;

Innovative dosage form drugs.

02

High-endmedical equipment

Medical imaging equipment, such as CT, MRI,

PET-CT, endoscopes, etc.

03

Digital healthcare/Medical robots

AI surgical planning and navigation, AI data modeling,

Surgical robots, rehabilitation robots.

04

IVD diagnostics

Tumors, chronic diseases, diabetes, innovative products; diagnostic reagents + instruments;Home self-testing products; molecular diagnostics, genetic testing.

05

High-value consumables

Cardiovascular interventional products, orthopedic implants, intracranial implants,

Intraocular lenses, pulmonary interventional therapy, dental products.