MAH Consulting Services

Service Background

The Marketing Authorization Holder (MAH) System in China, evolving from a pilot program to legislative enactment, represents a major reform and innovation in China's pharmaceutical supervision. It has transformed the traditional model where drug approval numbers are tied to manufacturing enterprises. Leveraging over 20 years of successful experience in pharmaceutical enterprise projects, we provide high-quality services for MAHs, including the establishment of a quality system for the full lifecycle of drugs and the optimization of talent structure.

Service Content

MAH System Establishment

The Marketing Authorization Holder (MAH) System in China, advancing from a pilot program to legislative implementation, is a pivotal reform and innovation in the country's pharmaceutical regulatory framework. It breaks the previous linkage between drug approval numbers and manufacturing enterprises. With our 20-plus years of proven success in pharmaceutical project management, we offer MAHs premium support in building a comprehensive quality system covering the entire drug lifecycle and optimizing their talent configuration.

Guidance on Application for Drug Production License (Category B)

《The Drug Production License (Category B) is a qualification certificate for MAHs to obtain drug production permission when adopting the entrusted production model (e.g., scenarios where R&D institutions entrust pharmaceutical manufacturing enterprises to conduct production). It is also one of the essential documents required for drug registration applications

Compliance Audit for Contract Manufacturing Enterprises

We provide comprehensive compliance audit services related to pharmaceutical production. Customized audit plans can be developed based on the characteristics of MAHs and their target products. Gap analysis can be conducted on contract manufacturing enterprises (Contract Manufacturing Organization - CMO or Contract Development and Manufacturing Organization - CDMO) from two aspects: the establishment of quality systems and the technology transfer of target products. A mature regulatory compliance report will be formulated for MAHs' reference and application.

Compliance Audit for Material Suppliers

We offer compliance audit services for all types of material suppliers, covering active pharmaceutical ingredients (APIs), excipients, packaging materials, and consumables. Depending on the MAH's application location and future development direction, gap analysis on material suppliers can be performed in accordance with the requirements of different regulations and guidelines such as ICH, ISO, and PIC/S.

Team Background

Over the past two decades, our company has developed a mature and standardized service system in areas including consultant team building, service standards, service procedures, project management, and confidentiality system. We have also passed the ISO 9001 Quality Management System Certification for consecutive years, making us one of the earliest consulting firms in China's pharmaceutical regulatory affairs field to obtain this certification.