Services for Pharma and Life-Science

 

 

FDA Registration

 

 

CMC Pharma GmbH offers FDA registration services for companies that produce pharmaceutical active substances or preparations (small molecules, biotech APIs), medical devices, food, or food additives.

We offer registration and updating of non-US firms to the FDA (Food and Drug Administration), so that a valid registration in the publicly accessible database of the FDA is displayed. Therefore, the current information about the submitted products, the DUNS Number and a "Letter of Non-Repudiation" have to be provided by the contractor. This information is reported correctly and timely to the FDA. Link for registration of pharmaceutical companies: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

On behalf of CMC Pharma GmbH, the US representative provides current information to the contractor that are necessary to maintain and care the registration and self-identification (Self Identification by GDUFA, "Generic Drug User Fee Act"), during the registration period (i.e., 1 year) . The US representative supports all related activities in direct communication with the FDA. The US representative forwards the communication of the FDA with respect to the contractor without delay to the contractor, e.g., dates of upcoming FDA inspection activities.

CMC Pharma GmbH informs the registered company three months before a registration follow-up is necessary about the pending re-registration. On receipt of this information, the contractor has the opportunity to negate the further re-registration. If the re-registration is not agreed, the US representative will provide the above mentioned activities until the current registration period is completed. We guarantee the confidentiality of any proprietary information, as well as the transfer of registration relevant data solely to the FDA.