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Veterinary Medicines

 

A veterinary medicinal product requires a marketing authorisation in accordance with Regulation (EC) No. 726/2004 to be placed on the European market. The Marketing Authorisation Application (MAA) must be prepared in a specified format for National, Mutual Recognition and Centralised procedures. 
The Drug Master File (DMF) application approach is essential for a company who manufactures an active ingredient and plans to license to third parties for sales as a veterinary medicine.
  
LKC provides you with…

  • Labelling strategies allowing a cost-effective and smooth entrance to the market;
  • Project management services for EU approval of active substances and national or union-wide authorisation of products, including label extensions, import tolerance settings and maximum residue limits, (MRLs) harmonisation of national distributors’ labels;
  • Selection, contracting and monitoring of studies compliant with guidelines and national practices (GLP & GMP) to ensure a high quality of scientific report for submission;
  • Comprehensive risk assessment reports in submission format;
  • Regulatory toxicology experience and know-how
  • Dossier preparation of Marketing Authorization Applications (MAA), Drug Master Files (DMF) and submission documents.
     

Contact LKC to discuss your requirements.
 

Related Information


Contact LKC

    LKC Switzerland Ltd
    Hauptstrasse 10
    P.O. Box 167
    4414 Füllinsdorf
    Switzerland
     
    Phone: +41 (0) 61 906 8500
    Fax: +41 (0) 61 906 8509
    LKC@lkc-ltd.com

     

      Veterinary Medicines

      • Pan EU approval 
      • New compounds for ectoparasitics

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