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

Services

License Application

ServicesMultination MAH/MAALicense Application

Becoming a Market Authorization Holder (MAH) is an important step for companies to achieve "separation of research, production, and marketing". However, the application for a MAH class B certificate involves complex procedures, such as verifying compliance of production sites, establishing a quality management system, and preparing for official inspection and approval. As a result, companies often face numerous challenges during the application process for a class B certificate: a lack of a professional team, unfamiliarity with pharmaceutical regulatory requirements, difficulties in efficiently preparing compliant application documents, and not knowing how to effectively communicate with regulatory authorities.

gempex can offer professional support in applying for MAH class B license. Thanks to our in-depth knowledge of the relevant regulations, we can help companies organize and prepare the complete set of documents required for the application. Additionally, we serve as a communication bridge between customers and the drug regulatory authorities, guide through the application process smoothly and reduce compliance risks. This saves time and costs.

Service Advantage

Full comprehensive services
We cover the entire lifecycle management from documents preparation, document creation and submission to certification and post market surveillance and vigilance, thereby reducing coordination costs of companies across various industries.

Expert team
Familiar with drug regulatory review criteria and processes for class B certificates,  our team precisely identifies key points and details of documentation requirements to avoid rejection or supplementary requests due to non-compliance, accelerating market access.

Practical guidance based on proven success
We transform our successful experiences into standardized operating procedures and service checklists, providing you with empirically validated guidance and support for your application.

advantage

Service Scope

1.  Documentation compiling guidance

We provide a detailed checklist to guide you in efficiently compiling and organizing all required materials, including supporting documents, qualification documents, and other necessary application materials.


2.  Application document writing

Write, organize, or review application documents to ensure they meet local submission standards.


3.  Submission and follow-up

Communicate with drug regulatory agencies in various countries on behalf of clients, complete the submission, correction, updating, and annual maintenance of materials.


4.  Inspection support

Linkked with "Inspection Support", we provide assistance with inspections by the authorities:

  • Before inspection: We provide inspection training support to help companies fully understand inspection requirements and prepare for inspections.
  • During inspection: We provide on-site support to ensure that the company has sufficient information to address inspection issues.
  • After inspection: We provide response and corrective action recommendations and expedite license issuance. 


Service Workflow