Freyr focuses on and offers support services that enable clients to effectively meet stringent requirements across diverse regulatory mandates.
Our portfolio currently encompasses the following mandate services:
Stability Data Services – 6M Accelerated and Real-time Data up to the shelf life data submissions for 3 validation batches for Europe
Biopharmaceutical products deteriorate and become unstable and ultimately unsafe as they age over time. The recommended days for which a product remains stable under specified storage conditions is referred to as the product’s shelf life.
Stability test is a set of experiment protocols conducted to collect data for estimating the stable shelf life of a product. There are two types of stability tests: real-time stability test, where the product is stored until it deteriorates, and accelerated stability test, where the product is stored under simulated stress conditions to determine the degeneration rate.
Regulatory Submissions of Periodic Safety Update Reports (PSUR)
Whether a product is marketed or not, Periodic Safety Update Reports (PSUR) have to be submitted once a product is registered in the EU. The primary objective of a PSUR is to provide periodic product safety updates at pre-defined times after registration. A PSUR contains all information data regarding the active ingredient, components, combinations, formulation, dosage, indications etc., for diverse populations (adults and children).
Commitments made to Health Authority
During the response to queries while seeking approval to market a product, many times companies give commitments (for the lack of the data at that particular point of time), which is mandatory to be fulfilled. As a health authority requirement commitments can be asked either before or after the marketing approval to gather additional product related information regarding the safety, effectiveness, or recommended usage.
First time Renewals
It is mandatory to submit a first time renewal application in Europe.
In accordance with Article 28 of Directive 2001/82/EC as amended by Directive 2004/28/EC, a marketing authorization (MA) is initially valid for five years, after which it may be renewed on the basis of re-evaluation of the benefit-risk balance.
Once renewed, the MA is usually valid for an unlimited period of time. However, on justified grounds relating to the pharmacovigilance, health authorities may decide to proceed with one additional five year renewal after which the authorization becomes valid for unlimited period of time.