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Regulatory services, Pharma, Biotech, Cosmetics, Medical Device
The Life Sciences market is growing and is expected to reach US$ 4,200 Million by the end of 2024. At the same time, the world is turning...
Regulatory Services, Medical Writing, Compliance, Auditing, Safety, PV
Global Regulatory Services Freyr’s Scientific and Medical writing team has proven expertise in delivering world-class Regulatory and...
Artwork Pack Management, Services, Support, Solutions, Consulting
Freyr Artwork Pack Management CoE provides innovative, cost effective, creative graphic design & artwork services to support new product...
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...
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