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

Services

Strategy Planing

ServicesMultination MAH/MAAStrategy Planing

Multiple MAH/MAA strategic planning in various countries has a significant impact on the global pharmaceutical market. A well-developed strategy can assist enterprises in achieving compliant and cost-optimized global product allocation with limited resources. However, in the face of diverse regulatory requirements across countries and limited resources of enterprises, how to make scientific decisions and optimize allocation has become a key challenge in the internationalization process of pharmaceutical companies.

gempex provides strategic planning services covering the entire MAH/MAA cycle according to the "global regulatory network + practical experience". Our professional team can help enterprises accurately compliance the requirements for market access, optimize the certification model and resource allocation, develop a compliant, efficient and executable global listing strategy to assist enterprises in building a globalization layout 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.

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

Successful MAH experience: We have served multiple enterprises in their MAH projects and assisted them in successfully obtaining production licenses.

Customized services:Develop strategies tailored to the unique circumstances of customers, while ensuring compliance, efficiency, and cost-effectiveness.

Whole process support: From strategic planning to applicant Holderregistration and functional site setup, 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 content:


  • Gap analysis:comprehensively evaluate the gap between the current certified structure, resource capabilities, and target market access requirements of the enterprise.
  • Regulatory interpretation:Provide analysis on the requirements for Applicant Holders, premises, quality management systems, and application processes specific to different target regions (such as China, EU, US, Southeast Asia, etc.).
  • Customized strategy design:Output clear and feasible strategic plans, including the selection of the Applicant Holders (self-holding/entrustment), allocation of functions and venues, prioritization of market planning, timeline, risk assessment, and response suggestions.
  • Reporting and Implementation:Provide professional strategy reporting, offer consultancy and coordination support during the subsequent implementation phase.