European Marketing Authorisations & Regulatory Affairs
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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

MaPP-Assessment
Haan, 21.07.2015 MaPP-Assessment/ADE (Acceptable Daily Exposure): EMA Guideline establishes Risk... 
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ProductLife Group acquires Keypharma
Paris, 13.04.2015 European life sciences specialist services provider  ProductLife... 
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Confirmation of General Manager
Haan, 30.03.2015 With effect from 30 March 2015, Holger Knoke has been permanently appointed as... 
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Latest Products

Azelastine eye drops multi dose, MAs in DE and PL available.

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 expected 4Q/15.
 
Sorafenib 200 mg FCT , Dossier expected 1Q/16.