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

Services

License Application

ServicesMultination MAH/MAALicense Application

Becoming a MAH holder is a core step for enterprises to achieve "separation of research, production, and marketing". However, the application for a B certificate involves complex procedures such as compliance review of production sites, establishment of a quality management system, and official inspection and approval. Nevertheless, enterprises often face numerous challenges during the application process for a B certificate: a lack of a professional team, unfamiliarity with pharmaceutical regulatory requirements, difficulties in efficiently preparing compliant application materials, and not knowing how to effectively communicate with regulatory authorities.

gempex can offer professional assistance in applying for MAH B license. Leveraging our in-depth understanding of relevant regulations, we can help enterprises organize and prepare the complete set of materials required for the application. Additionally, we serve as a communication bridge between you and the drug regulatory authorities, guiding you through the application process smoothly, reducing compliance risks, and saving time and labor costs.

Service Advantage

Integrated service capability: Covering the entire lifecycle management from data preparation, writing, submission, certification to post-market supervision, reducing the coordination costs of enterprises across multiple lines.

Professional team: Familiar with the key points and procedures of B-certificate review by the drug regulatory authority, able to accurately grasp the key points and details of data preparation, avoid rejection or supplementary requirements due to non-compliant data, and accelerate market access.

Practical guidance based on successful experiences: We convert our limited successful experiences into standardized operational procedures and service checklists, providing you with experimentally validation guidance and support for your application.

advantage

Service Scope

1. Material collection guidance: Provide a detailed list of materials, guiding you to efficiently collect and organize 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. Official inspection support: Associate with "Inspection Support" to provide assistance for official inspections:


  • Before inspection: Provide inspection training support to help enterprises fully understand inspection requirements and prepare for inspections.
  • During inspection: Provide on-site support to ensure that the enterprise has sufficient information to respond to the inspection.
  • After inspection: Provide a response and rectification suggestions, and facilitate the rapid issuance of the license.