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Study Data, legacy conversions, CDISC, FDA, Publishing, Submissions
Study data is information about a person in a clinical trial. It includes demographic information, details of medical treatment,...
DMF Submissions, eCTD format, USFDA, EDMF, ASMF Submissions
Drug Master File (DMF) is a file that is used to provide confidential and detailed information about facilities, and processes used in...
Regulatory Product Submission, RPS, HL7 standard, USFDA
Regulatory Product Submission (RPS) is an HL7 standard introduced by the US Food and Drug Administration (FDA Submission). As defined in...
Structure Product Labeling, SPL Submissions, HL7 SPL, FDA
As per the United States Food and Drug Administration (USFDA) norms, adopting technology, its processing, managing, labeling and details...
Clinical Study Report, CSR Publishing, Submissions
The Clinical Study Report (CSR) is an “integrated” report of an individual study mainly aimed at efficacy and safety. It includes results...
Paper Submissions, CTD format, paper to eCTD format
Although the electronic common technical document (eCTD) has been set as a standard format by majority of Health Authorities (HAs), a...
NeeS submission, NeeS publishing, Non-eCTD, NeeS format
Non-eCTD electronic Submission (NeeS) format has been made mandatory in the European Union(EU) from 2003 onwards. When compared to the...
eCTD Publishing, format, e Submissions, Regulatory Submissions
eCTD (electronic Common Technical Document) is an electronic format that supports the submission of applications, amendments, supplements...
Regulatory Publishing, Submissions, eCTD, NeeS format
Freyr assists Life sciences organizations streamline entire Health Authority (HA) Submission Management Process, right from dossier...
Handling Health Authority queries, pharma/Biological products
The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted...
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