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.

Veterinary Medicines Products

Pan EU approval

New compounds for ectoparasitics

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Contact

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

Information

Registration Number: CHE-113.597.134

2007-2020 © Copyright LKC Switzerland Ltd

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