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A national high-tech enterprise in the field of biomedicine.

 

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Drug stability sample box
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Drug stability sample box

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Analysis instrument
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介绍

The drug stability sample box is in accordance with the requirements of the GMP principle and the long-term stability test conditions of 25℃/60%RH humidity. In the accelerated test, the humidity of 40°C/75%RH is checked for 6 months, which mainly simulates the temperature, humidity and light test in the environmental climate.

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Drug strong light irradiation test box
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Drug strong light irradiation test box

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Product Lifecycle Management

Product Lifecycle Management
Product Lifecycle Management
Quality System and Registration

Quality System and Registration
Quality System and Registration
Regulatory Affairs

Regulatory Affairs

Our Team offers CMC documentation support for IND, CTA, MAA, NDA and ANDA applications in western countries and China. Our highly experienced team works to prepare Module 2 and Module 3 of your regulatory dossier through forward-looking gap analysis and meticulous preparation of source documents. Our dedicated team can add tremendous value to your development program and speed time to market. 
Regulatory Affairs
Chemical R & D

Chemical R & D

Development of chemical process and selection of process route
Chemical R & D
Analytical R & D

Analytical R & D

Our analytical chemists provide comprehensive analytical testing support for process development and drug substance and drug product manufacturing. Our analytical team follows regulatory guidances on supply chain assurance for quality control.
Analytical R & D
Formulation R & D

Formulation R & D

Physical pharmaceutical properties
Formulation R & D
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