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.

 

“Seriousness, reliability and proximity to our customers are our most important targets"

 

Judith Jech, Managing Director

"Our international network consisting of cooperation partners and customers enables us to offer state-of-the art pharmaceutical dossiers and marketing authorisations to you"


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

PSUR Docetaxel
Haan, 31.10.2013 A PSUR is still required for generic Docetaxel marketing authorisations. According... 
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PSUR Epirubicin
Haan, 31.03.2014 A PSUR is still required for generic Epirubicin marketing authorisations. The... 
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Acquisition by ProductLife
5 March 2014 It is with great pleasure that Kohne Pharma (KP) announce the acquisition of the... 
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Latest Products

Acetylcystein 200 and 600 mg effervescent tablets, German MAs granted 11/2011.

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

Azelastine eye drops single dose, Dossier ready for submission.

Olopatadin eye drops, Dossier ready for submission.