Service Scope

Biomedical Information/Clinical Project Operation/New Drug Registration

  • Drug Information

    Project Support and Drug Commercialization Strategy

  • Product Registration

    Smooth Execution of approval by CFDA

  • Clinical Research

    Project Management, Clinical Trial Monitoring, Data Management and Medical Support

  • Quality Control

    Implementation of Audit, Personnel Training and Risk Management

  • Central Laboratory

    Biological Sample Testing including Bioequivalence and Pharmacokinetics Study

About us

A CRO company specialized in clinical trial solutions and services for innovative generic drug and devices.

Genco Medical was established in 2014 with the registration capital of 24 million RMB. As an innovative CRO company, we are dedicated to provide high quality services to our customers.

We provide a wide range of services related to IND, NDA & ANDA registration, medical device registration, regulatory intelligence, clinical project management and operation, data management and statistics. With our path-breaking working strategy and experienced team members, we can foster your success in drug development and  marketing approval of the new drug in China.

Genco Medical team consist of professionals with diverse educational background including clinical medicine, pharmacy, biomedical science, nursing, biology, management and statistics etc. With ample knowledge and profound case experience and dedication, our team is committed to be a reliable partner to our customers.

About us Shenyang Beijing Wuhan Chengdu Guangzhou Urumchi Lhasa About us Shenyang Beijing Wuhan Guangzhou Chengdu Lhasa Urumchi

Our Excellency

An experienced team from diverse educational field with hard working spirit.

Regulatory Expertise

Leb by former CFDA/CDE reviewers,Genco's regulatory team can provide valuable insight and appropriate strategy to our clients according to the latest regulations base on the breadth and depth of our hundreds of project experience.Accordingly,we will facilitate the registration of pharmaceutical products and push the access to Chinese market successfully and timely.
● Regulatory feasibility & strategy
● CFDA/CDE experts consultation meeting
● Indication & Labelling
● Registration of API, FDF and excipients
● Dossier (CTD format) preparation and submission

Regulatory Expertise

Operation Excellency

Our project design team consists of experts in the field of medicine, regulatory affairs and biostatistics which has been an efficient measure to provide maximum compliance with the regulatory requirements. Our research experience covers following areas:
● Clinical research application including meetings with CFDA and CMDE professional for best project design
● BE study
● PK&PD study
● Clinical Trials (Phase II and III)
● Adverse Drug Reaction Monitoring
● Research Project Management based on ICH-GCP and Domestic Regulatory Standards

Operation Excellency

Quality Assurance

Our quality management system is abided by international standards.We are strictly concerned to
● Standard Operating Procedure (SOP)
● Customized Training System
● Quality Control Documents
● Electronic Data Management
● Corrective and Preventive Action (CAPA) system
● Risk Management System
● Risk-based Extra Monitoring

Quality Assurance

Cost Effective

With in-depth understanding of regulatory requirements in China, we are pleased to offer our customers maximum output with limited investment.
● For collaborative research, we can provide rational design of research program and project implementation design
● We employ effective measures to improve BE study which has resulted into increased frequency of the successful clinical trials
● By employing self-developed management system, we have reduced management cost to the minimum while increasing its efficiency hand in hand

Cost Effective

Harmony is not Similarity.

How can we providing high quality services to our customer?

  •  Clinical operations director Luo Qi

    What is the secret of high quality service? There are a few important points that counts a lot, like SOP specifications

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  • Eric Chen, Project Director

    Each clinical study project is associated with some risks and a good project team reduces the risk by utilizing

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  • Summer Zhang, Clinical Research Manager

    For a good quality service, CRO should be able to integrate the quality control requirements efficiently and ensure

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  • Alex Liu, Project Manager

    I consider following few aspects to be very important in maintaining good quality control of a clinical research project

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For any further query, you are welcome to contact us via following contact methods.

  • Telephone


  • E-mail

  • Job opportunities

  • WeChat