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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...
Regulatory Consulting, Dossier Preparation, Submission, Registration
As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and...
Regulatory Assessment, Gap Analysis, Pharma, Biological products
Regulatory assessment is a key activity in registration and life cycle maintenance of Pharmaceutical and Biological products. It is...
DMF, ASMF, CEP Submissions, eCTD, USFDA, EMA
Filing Active Pharmaceutical Ingredient (API)/Excipient information separately to Health Authorities (HAs) is not mandatory. However, to...
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