DMF application and FDA certification

Mar. 25th, 2014

According to US Federal Administrative Law, there is a Drug Master File (DMF) must be provided for pharmaceutical ingredient entering into United States. It is a document that provides detailed interpretation of a drug manufacture process, which would help FDA to have a comprehensive understanding of the manufacturing plant. The latter will issue certification to allow the applying products to place on US market.

Our Service Includes:
>> Compilation and delivery of DMF to FDA
>> Acquisition of DMF distribution number and NDC registration number
>> DMF annual update
>> Help company to prepare materials for obtaining FDA certification
>> Assist company to confront regular random inspection

About REACH24H
REACH24H Group provides product stewardship & regulatory compliance service for global customers from its three offices – Ireland, Canada and China, assisting international companies to comply with global chemical regulations including the EU REACH, China new chemical substance notification, Global GHS, USA TSCA, etc. REACH24H in-house team consists of global-regulatory experts, toxicologists, environmental risk assessors, chemical engineers and IT software development engineers to provide cost-effective access to the marketplace for the clients. REACH24H Consulting Group is also the sub-company of Centre Testing International Corporation (CTI) , a publicly traded company on the Chinese Stock Exchange(300012.SZ). CTI is China’s leading product testing, inspection, certification, and consulting firm, providing comprehensive services for virtually all consumer products. For more information on REACH24H, please Contact us or visit About us.