Veterinary Medicine and Pharmaceuticals

Achieving Human and Veterinary Medicinal Product EU Regulatory Approval

Are you seeking to market your pharmaceutical and veterinary products within Europe? If so, you’ll find the regulatory process both stringent and lengthy. However, being a European based consultancy, LKC helps make the process faster and more likely to succeed.

Our wide range of resources are available to support your non-clinical overviews, data gap analysis, master file preparation, PBT, environmental risk assessments, and lots more.

Newsletter Links

December 2022 – January 2022

‘Click’ chemistry may help treat dogs with bone cancer, learn more here.

RCVS Knowledge is launching a new course to improve veterinary medication safety. Find out more.

Additionally, our technical toxicology resources can assist in the toxicological assessment of elemental impurities according to both ICH Q3D and ICH M7, including computational screening, using multiple in silico tools (QSAR).

Plus, our environmental resources help you achieve successful environmental and PBT risk assessments to Environmental Quality Standards (EQS).

 

Maximum Residue Limits submissions (MRL dossiers)

To reduce any risks to humans eating animal products, LKC calculates the toxicological values and MRL in milk, eggs and meat, for submission to the European Medicines Agency. See Related Agrochemical Capabilities.

 

LKC’s service includes:

  • Project management services for EU approval of active substances and national or union-wide authorisation of products, including label extensions, import tolerance settings and harmonisation of national distributors’ labels
  • Writing high quality scientific reports for submission, including data gap analysis, summary and dossier writing
  • Compiling the Active Substance Master File (ASMF) and dossier sections for Marketing Authorisation Approval (MAA), including variations (MAV) when needed
  • Human Exposure Assessment or User Safety Risk Assessment (USRA) of the veterinary medicine product, such as the likely toxicology of untested compounds or user safety studies, and reporting in dossier
  • Labelling strategies allowing a cost-effective and smooth entrance to the market
  • Selection, contracting and monitoring of studies compliant with guidelines and national practices (GLP and GMP) to ensure a high quality of scientific reporting for submission

LKC’s expert support helps to ensure your pharmaceutical and veterinary active substances and products achieve regulation within the EU, Switzerland and the UK. Talk to LKC today to discover how we support you through the process, propelling your sales opportunities within Europe. Email LKC@lkc-ltd.com or telephone +41 (0) 61 906 8500.

Latest Regulatory News

Jan-2023

Biocides > News

Updates to Efficacy Requirements for Biocides

In November 2022, ECHA published version 5.0 of Guidance on BPR Volume II for efficacy. The updates include new guidance on co-formulants, differentiation of claims...

Read More

Dec-2022

Crop Protection > News

Commission addresses the availability and affordability of fertilisers

Fertilisers play a significant role in food security. Their production and their cost largely depend on natural gas. Following Russia's invasion of Ukraine in February...

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Contact

LKC Switzerland Ltd
P.O. Box 167
4414 Füllinsdorf
Switzerland

Phone: +41 (0) 61 906 8500
LKC@lkc-ltd.com

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Registration Number: CHE-113.597.134

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