Europe - Animal Health
TSGE’s team of scientists and regulatory experts guide companies through the
regulatory requirements for animal health products under Directive 2001/82/EC
amended). This includes preparing complete or partial dossiers, carrying out
quality, safety (including toxicology, residues and environmental safety) and
efficacy expert reports, or detailed and critical summaries. TSGE can handle all
aspects of safety and residues required under Regulation (EC) No 470/2009. TSGE
also offers expert advice in veterinary pharmacovigilance, preparing reports
(including PSURs) and providing pre-audit and pre-inspection services and
advice. In addition, TSGE provides guidance on strategy needed to effectively
obtain National and/or European registration so companies can obtain a marketing
authorization in a quick and timely manner.
Safety, toxicology and ecotoxicology:
TSGE provides expert advice on data requirements, suitability of studies,
maximum residue levels (MRLs), phase I and II assessments, expert statements and
reports, monographs, user safety assessments, data interpretation, review of
literature and labeling, and negotiation with regulatory authorities.
search literature for adverse effects of specific products, actives,
excipients and other ingredients, drafts PSURs, and prepares for internal
audits and regulatory inspections. In addition, TSGE identifies document requirements (SOPs, business procedures and manuals), drafts, and reviews SOPs and related documents. TSGE also advises on audits and
inspections, constructs CAPA plans and responses, interprets data and
negotiates with regulatory authorities.
requirements: TSGE assist with data inspections,
dossier examination, compliance checks, pharmacovigilance checks and