Service Background

In the pharmaceutical field, MAH certified conversion services help companies or individuals that have R&D and innovation capabilities but probably without production capabilities to successfully convert their R&D products into legally marketed products. Specifically, under the MAH (Marketing Authorization Holder) system, R&D units do not need to build their own production lines and can directly apply for drug marketing authorization certificates. MAH certified conversion service providers play the role of a bridge.

Drug MAH Certification Conversion Service

Service Purpose
We propose solutions around the entire process of how to make a drug legal, compliant and efficient from the laboratory to the market, helping R&D entities focus on their core R&D activities and reduce entry barriers and operating costs.

Service scope
1. Guide customers to establish MAH quality system and assist in applying for B license
2. Provide MAH holding service for enterprises without B license
3. Customize and develop target products according to customer needs and obtain approval
4. Implement suitable industrial bases
5. Provide quality management system construction services for drugs after lunched
6. Continuous product quality improvement services

Build a joint certification platform
1. Build a joint certification company
2. Provide a research and development industrialization platform
3. Provide a quality management system
4. Partners provide a sales platform

Service Targets
1. Innovative biotechnology companies
2. Small and medium-sized pharmaceutical companies
3. CROs
4. Drug holders or teams

Our advantages

1. Formulation Department
Lead by PhDs, with a master's degree with decades of work experience as research assistant, we are committed to the development and industrialization of oral solid formulation, lyophilized formulation, injections, ophthalmic formulation and complex injections. Multiple formulation project teams, fully equipped with: freeze drier, capping machine, dry granulation, wet granulation, process bed, coating machine, tablet press, capsule filling machine, high-pressure homogenizer and other formulation preparation equipment.

2. Raw Materials Department
Lead by senior PhDs, expert, team members have completed the development and industrialization of hundreds of difficult raw materials, and have obvious advantages in the fields of Carbapenems, -tinib, Gadolinium contrast agents, etc.
Equipped with 50 Test Batch fume hoods, hydrogenation reaction room and 100L Pilot Batch laboratory.

3. Quality Research Department
The domestic first-class quality research team has a high reputation in the fields of drug quality research, impurity research, and genotoxic impurity research. Team members have completed the development and verification of 500+ analytical methods and have rich experience and theoretical foundation.
Equipped with two-dimensional liquid chromatography from Agilent 1290 ultra-high performance liquid phase with 6530 time-of-flight mass spectrometer. QE from Thermo Fisher. There are more than 20 HPLCs, 2 GCs, ICP-MS, IC, TGA, DSC, UV, 4 automatic sampling dissolution instruments, conductivity, residual oxygen, and dissolved oxygen measuring instruments.

Service process