We provide professional GMP compliance audits for chemicals, biologics and APIs, excipients and packaging materials to help pharmaceutical companies and pharmaceutical companies improve their quality systems, covering third party audits and gap analysis/simulation audits.
- We have a professional audit team with an independent perspective and a high degree of credibility to provide third-party audit services to our clients.
- We can conduct an In-depth audit of the modules of the system to identify gaps, assess the problems found and can provide targeted solutions according to demand, and follow up on acceptance.
After more than two decades of development, the company has a perfect system structure and the relevant technical personnel have in-depth research and understanding of domestic and international GMP-related regulations and guidelines.
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26years’
practices in pharmaceutical industry
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1370+
Global clients and partners
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700+
Global GMP inspection & certification projects
We always have a good communication with authorities, closely follow-up the updated industry trends, and establish a fully-fledged information and documents database, which enable us to have strong information integrating and analyzing capabilities so as to share with our clients and support them from R&D system establishment, clinical trials operation, RA, GMP compliance and MAH related support.