Our team of scientists can guide you step-by-step through interpreting and understanding the requirements of animal health products under Directive 2001/82/EC (as amended).
Whether you need us to provide expert regulatory advice, prepare complete or partial dossiers, carry out quality, safety (including toxicology, residues and environmental safety) and efficacy expert reports or detailed and critical summaries - we are here to help.
We regularly complete risk assessments or monitor studies for the registration of products and our experience in many regulated chemical sectors over a wide range of product uses is at your disposal.
We can handle all aspects of safety and residues required under Regulation (EC) No 470/2009. We can also offer expert advice in veterinary pharmacovigilance, preparing reports (including PSURs) and providing pre-audit and pre-inspection services and advice.
We are also able to provide guidance on the strategy to be followed in order to effectively obtain National and/or European registration, so your product is more likely to obtain a marketing authorisation more quickly.
Areas in which we are able to advise and provide services on include:-
Safety, toxicology & ecotoxicology - Expert advice on data requirements, suitability of studies, maximum residue limits (MRLs), phase I and II assessments, expert statements and reports, monographs, user safety assessments, data interpretation, literature reviews, review of product literature and labelling or negotiation with regulatory authorities.
Pharmacovigilance expertise - Literature searching for adverse effects of specific products, actives, excipients and other ingredients, drafting of PSURs, preparation for internal audits and regulatory inspections, identification of document requirements - SOPs, business procedures, manuals, drafting and review of SOPs and other related documents, advice relating to audit and inspection observations, construction of CAPA plans and responses, interpretation of data, expert statements and reports and negotiation with regulatory authorities.
Training services - In-house training, interpretation of data, regulatory requirements, audits and inspections, CAPA plans and responses, SOPs and other related documents, dealing with inspections, regulatory authorities, reporting requirements, causality and expectedness, ABON coding, role of Qualified Person for Pharmacovigilance.
Due diligence requirements - Data inspection, dossier examination, compliance checks, pharmacovigilance checks and regulatory correspondence.