thinspring.com
About company
Structured Content Authoring, specializing in FDA regulatory compliance software, services, and submissions for Structured Product Labeling - SPL. This includes Product Labels, Labeler Code Requests, Establishment Registration, Lot Distribution Reporting - LDR, Risk Evaluation and Mitigation Strategy - REMS, Generic Drug Facility Identification - GDFI and Physician Labeling Rule - PLR. We also service Individual Case Safety Reports - ICSR, Electronic Medical Device Reporting - EMDR, and Electronic Common Technical Document - ECTD. Health Canada - HC and CESG submission for eCTD, Structured Product Monograph - SPM and Non-eCTD electronic Submissions - NeeS. In addition, we provide AS2 automated submission services and will return all relevant documents and receipts upon success.
