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

Services

Production License Application and Inspection

ServicesMultination MAH/MAAProduction License Application and Inspection

Successfully obtaining a drug manufacturing license is important for every company. However, all activities take the time and cost for the company, e.g., how to submit the compliant and complete materials to the authorities, the progress of license application follow-up and necessary support, etc. It also helpful to have professional personnel to participate before and during the inspection.

gempex can support customers for solving the above-mentioned difficulties, and we can provide the services of production license application and inspection support.

Service Advantage

Technical expert team with professional background in pharmaceutical, biological and other fields

Served many enterprises for MAH projects with successfully obtaining production licenses

Experienced in support domestic enterprises for official inspection or prepare for inspection

advantage

The Service Contents

1. Production license application: review and support application materials / documents

2. Inspection support：

  • Before inspection: provide training for inspection preparation, help the company understanding the requirements of the inspection and be fully prepared for the inspection.
  • During inspection: provide on-site support, and support the company with more confidence for inspection.
  • After the on-site inspection: provide responses and corrective suggestions ifnecessary to fully respond to the relevant requirements from authorities.