As of June, 2009, NDC code requests, establishment registrations, and drug listings must be submitted to FDA electronically using extensible markup language (XML) in SPL format (Refer to FDA’s Guidance for Industry, Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing).
SPL conversion and submission is tedious and time-consuming and completing the electronic forms is not intuitively obvious. The SPL formatting requirements are very detailed and specific, e.g. a misplaced blank space will cause an error, a field left blank may cause an error, an incorrect citation for an NDA or ANDA number or an OTC monograph will cause an error, not being able to access a label image will cause an error. CSLLC can make the submission for you or can assist you in completing the submission forms and/ or trouble shooting errors returned from the validation process or from the FDA Gateway.
e-Submissions for Medical Device Companies
CSLLC can also assist medical device companies in the complicated process of registering and listing their devices. This includes assistance with FDA’s Unified Registration and Listing System (FURLS) and the Device Registration and Listing Module (DRLM). But there's no regulation that says you have to do it by yourself. Compliance Specialists, L.L.C. can help you complete and submit these filings. Compliance Specialists, L.L.C provides e-submission Registration, Update, and Renewal assistance for U.S. and Non-U.S. companies in the Drug and Medical Device industries.