• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

Market Authorization Strategy Planning

ServicesMultination MAH/MAAMarket Authorization Strategy Planning

MAH/MAA strategic planning in various countries has a significant impact on global pharmaceutical market authorizations. A well-developed strategy can assist companies in achieving compliant and cost-optimized global product approval with limited resources. However, with view to different regulatory requirements across countries and limited resources of companies, scientific decisions and optimization of market access have become a key challenge in the internationalization process of pharmaceutical companies.

gempex provides strategic planning services covering the entire MAH/MAA process based on the "global regulatory network knowledge + practical experience". Our professional team can help companies accurately meet the requirements for market access, optimize the certification model and resource allocation, develop a compliant, efficient and executable global licensing strategy to assist companies in developing a globalization plan.

Service Advantage

International team
German, Switzerland, and Chinese teams + American partners, with a deep understanding of MAH/MAA regulatory requirements in China, EU, and U.S., and familiarity with different market access processes and configuration requirements.German, Switzerland, and Chinese teams as well as American partners, with a deep understanding of MAH/MAA regulatory requirements of EMA, FDA and NMPA are familiar with different market access procedures and specific demands.

Rich audit experience
The team possesses extensive domestic and foreign audit experience, is familiar with the characteristics of quality systems in various types of companies and is able to quickly identify weaknesses in quality systems, providing systematic suggestions for improvement.

Experience in successful MAH projects
We have served many different companies in their MAH projects and assisted them in successfully obtaining licenses as marketing authorization holders.

Customized services
We develop strategies tailored to the specific needs of our customers, while ensuring compliance, efficiency, and cost-effectiveness.

Entire process support
From strategic planning  and obtained MAH license to the start of operations, we provide accompanying services tailored to the business development of our clients.

advantage

Service Scope

We provide professional support for the entire process of MAH/MAA strategy planning, covering the following services: 


  • Gap analysis
    We comprehensively evaluate the gap between the current status of certification, resource capabilities, and requirements for market access targets of the company.


  • Regulatory consultancy
    We provide analysis on the regulatory requirements for Application Holders regarding premises, quality management systems, and processes for approval specific to different target regions (such as China, EU, US, Southeast Asia, etc.).


  • Customized strategy design
    We provide clear and feasible strategic plans, including the selection of Application Holders (self-holding/entrustment), allocation of functions and venues, prioritization of planned market access, timeline, risk assessment, and recommendations for procedures.


  • Monitoring and guidance during implementation
    We provide professional monitoring of the strategy implementation process, offer consultancy and coordination support during the subsequent implementation phase.


Service Workflow