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eCTD Submission Services & Software Solutions FDA, EMA
We offer eCTD Submission & Publishing services to Life Sciences Industry for approval of Drugs/Medicines, Converting Non-eCTD...
Health Authority Queries – Responses | Interactions
The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted...
Regulatory Affairs Consulting
As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and...
Regualtory Assessment | Gap Analysis
Regulatory assessment is a key activity in registration and life cycle maintenance of Pharmaceutical and Biological products. It is...
Post Approval - CMC and Life Cycle Management
Freyr is a leading player in Centralized Chemistry, Manufacturing and Controls (CMC) and Life Cycle Dossier Management, offering services...
New Market Authorizations - APIs
Freyr offers all types of API/Excipient initial submission services like DMF, ASMF, CEP across the globe including chemical,...
New Product Authorizations for Pharma - Finished Products
Freyr is a preferred Regulatory Affairs partner for new market authorizations / initial submissions to global clients, for all types of...
Global Regulatory Affairs Services
Freyr provides comprehensive Regulatory services across the spectrum of global product development, registration and commercialization....
Commercial INDs in eCTD Format What it takes for the Paper to eCTD Switchover?
An Investigational New Drug (IND) sponsored by a corporate entity is considered as a ‘Commercial IND.’ Center for Drug Evaluation and...
FDA’s Pregnancy, Lactation and Labeling Rule (PLLR) Get Insights on Section-wise Changes
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June...
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