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Development & Registration

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Quality system and registratio

Quality system and registration

Our quality system has passed numerous quality audits from big pharma companies and is in compliance with regulatory requirements. Our GMP API and drug product manufacturing facility is qualified for manufacturing GMP API and drug product to support clinical trials worldwide.

● Quality assurance system follows ICH Quality Guidelines and supports API and drug product development and manufacturing in compliance with FDA, NMPA and EMA for all cGMP requirements

● Regulatory support preparation for full data packages and documentation for regulatory filing

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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. 

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