International Regulatory Support:
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 (as A dog before receiving medical treatment using an EU-regulated animal health productamended). 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.

Pharmacovigilance:

TSGE helps 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.

Due diligence requirements:

TSGE assist with data inspections, dossier examination, compliance checks, pharmacovigilance checks and regulatory correspondence.
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