European Marketing Authorisations & Regulatory Affairs
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Kohne-Pharma

REGULATORY AFFAIRS - PHARMA CONSULTING

Welcome to Kohne Pharma!

With Kohne Pharma you choose a reliable partner who possesses specific experience and capabilities in the field of regulatory affairs. As a full-service-provider we pursue German application procedures as well as MR- and DC procedures within the EEA on your behalf.

We process the whole planning and realisation of the longwinded and labour-intensive application procedures on your request. Additionally, we support you in maintaining your marketing authorisations in a permanently altering regulatory environment.

The growing demand for perfect solutions has prompted us to enlarge our offer of proprietary marketing authorisations. Our portfolio of marketing authorisations covers a broad spectrum nowadays.

Besides our proprietary marketing authorisations with an emphasis on oncological, hospital, and ophthalmic products we also offer pharmaceutical dossiers and marketing authorisations of our cooperation partners and customers from both the domestic area and abroad.

You can obtain additional information about our business segments here.





 

News

eCTD preparation
Haan, 25.01.2017 Since 1 January 2017 applications for marketing authorisation within mutual... 
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Blue hand - New symbol
Haan, 01.12.2016 The „blue hand“ is a new symbol in Germany which indicates Educational... 
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MaPP-Assessment
Haan, 21.07.2015 MaPP-Assessment/ADE (Acceptable Daily Exposure): EMA Guideline establishes Risk... 
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Latest Products

Aripiprazol oral solution, Dossier ready.

Calcipotriol lotion, Dossier available.

Chlortalidon tablets, Development project.

Rasagilin tablets 1 mg, Dossier ready.
 
Sildenafil tablets 20 mg (Cardio-Vascular), Dossier ready.

Sorafenib 200 mg FCT , Dossier expected 1Q/18.