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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...
IND, NDA, ANDA, BLA, NDA, Submissions, Applications
Freyr specializes in Dossier strategy, Dossier Gap Analysis, Dossier Compilation, Regulatory Content Authoring, Validation and final...
Drug Regulatory Affairs Services
Drug Regulatory Affairs Freyr’s global Regulatory affairs expertise enables Life Sciences, Consumer Pharma and Bio-Med companies...
Global Regulatory Services & Solutions
Regulatory Operations A Leading, Global, Regulatory Solutions & Services Company Supporting, Large, Mid & Small global Life Sciences...
ectd software services
Smarter the eCTD publishing software, smoother will be the eCTD submissions process. But to ensure the smoother submissions, life...
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