All European Marketing Authorisation Holders are concerned by Nitrosamine Regulatory Actions

There is serious workload expected from all marketing authorisation holders (MAH) in EU! Let’s see what is expected for MAH compliance related to nitrosamines.

On 26 September 2019, the EMA published a statement titled “EMA advises companies on steps to take to avoid nitrosamines in human medicines (EMA/511347/2019)“. With regard to the Art. 5(3) referral, MAHs are requested to evaluate the risk of the presence of nitrosamine impurities in their human medicinal products containing chemically synthesized active pharmaceutical ingredients (“Information on nitrosamines for marketing authorisation holders:”).  

FarmavitaR Outsourcing

European "One-Stop-Shop" for Regulatory and Market Access Support

FarmavitaR+ is not only platform for on-line hiring of consultants, experts and freelances. We are also "one-stop-shop" for complex international projects.  To manufacturers of pharmaceuticals, biopharmaceutucals and medical devices, we offer "one-stop-shop" service across the 90+ countries worldwide.  

Our carefully selected team of local associates communicate daily with national regulators and payers at those matkets. This is the core of our business.

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Turkey - Growing Market and Pharmaceutical Hub 

As you all knew, at the end of July 2016, Turkey has suffered a failed coup attempt.   After that the government took some serious even excessive measures to clean the putschist or anyone related to these people from the state agencies. Around 80,000 personnel, working at the different agencies of the State were either fired or suspended. At the Ministry of Health, 115 senior director, 1504 physician, total 5581 personnel have been removed from duty.

First FarmavitaR+ / regulanet conference

More than 25 participants met recently in Zagreb to explore and prepare for collaborations with the associates of FarmavitaR+ (FvR+) in Central, Eastern and South-eastern Europe.

Graciously hosted by FvR+ Managing Director Zdravko Mauko, the three day event included presentations on regulanet members, quality standards and working methods by Jürgen Regenold, Brad Clemmons and Alfonso von Wunscheim from regulanet, as well as SOP trainings led by Zdravko Mauko from FvR+ and Sonja Krisam from regulanet. FvR+ associates participated in training on regulanet core SOPs and received an introduction to R+ docuBridge SOPs.

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Breakthrough in global regulatory affairs projects:

FarmavitaR+ Formed as a Strategic Alliance of Regulanet® and Farmavita.Net

Farmavita.Net and regulanet® AG have established FarmavitaR+®, a joint venture company delivering high-quality regulatory affairs services to clients for pharmaceutical projects in Central, Eastern and Southern Europe.