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.

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

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.