BFC-Lite Solution can help customer to start complying with the Regulations
Starting from safety database upgradation to data extraction and processing the data to support ICSR R3 file format is key challenge to any Pharma company. BFC lite plays vital role in order to comply and meet regulatory requirements. With BFC Lite, most of our partners seen improved quality in reports by keeping operational cost marginally low. BFC Lite helps to transform R3 files received from one Regulatory Authority/Partner may need to be reported in R2 format to another Regulatory Authority/Partner.
BFC Lite is proven solution and tool to generate R3 file using your safety database or existing R2 File.
In General we take 4 to 6 Weeks time to study and signoff your business requirement.
Upgrade includes – Data Migration, New Business Processes, Training of the new Safety System and R3 fields.
Blog Electronic submissions for IND Safety Reports to FAERS Key Highlights Starting June 28, 2021,...
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Olcay is our technology partner for regulatory reports.