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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...
Who is A Mexican Registration Holder (MRH)?
Mexico is possibly one of the most lucrative markets in Latin America, particularly for exporting medical devices. According to local...
United States Pharmacopeia’s New Applicability Date on Elemental Impurities – Decode the Essentials
Finished drug products contain minute amount of impurities which find their way into drugs at various junctures of manufacturing. They...
eTMF Management, eTMF software, electronic Trial Master File
Freyr eTMF software Audit & Inspection readiness - The first and foremost aspect every Pharma company / a Contract Research Organization...
Identification of Medicinal Products (IDMP)
Some advancements in the system bring along potential opportunities for significant improvements in the processes. On the same line, to...
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