Veterinary Services

Our expertise, for the quality of your animal health products.

  • Pharmacovigilance for Veterinary Medicinal Products
  • Regulatory Intelligence and Services for Veterinary Medicinal Product
  • Veterinary Good Vigilance Practice
  • Good Manufacturing Practice for Veterinary plants
  • Good Distribution Practice for Veterinary Medicinal Products & active substances
  • Good Laboratory Practice for your Veterinary QC lab
  • Good Clinical Practice for the Efficacy and Safety of your Veterianry medicinal Products
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How can my company achieve compliance?

PQE Group, thanks to the vast 20+ years of experience in LifeSciences can support veterinary medicinal manufacturers and Marketing Authorization Holder approaching the regulations to solve compliance related issues at global level.

Our services for the Veterinary pharma companies

VGVP (Veterinary Pharmacovigilance)​

  • Policies/Manuals/SOP/WI development, issuing, review​
  • Customized training​
  • CAPA Management​
  • GAP analysis​
  • PV System Master File (PSMF) Implementation​
  • Audit risk analysis (planning)​
  • Internal system audits and external audits​
  • KPI (setting and evaluation)​
  • Signal Management​
  • EVVet and safety database management​
  • PV Quality Assurance outsourcing​
  • EU-QPPV outsourcing​
  • Local Representative​

Regulatory Affairs​

  • SPC Review /drafting (QRD Template V9)​
  • ICHQ3D risk assessment​
  • VMP prescription classification​
  • Safety and Residues evaluation​
  • Regulatory Startegic plan​
  • Marketing Authorization Application​
  • Dossier drafting, GAP analysis & fixing​
  • Dossier reformatting & submission​
  • Lifecycle Management​

GMP / GDP​

  • Inspection Readiness Programs​
  • CAPA Management​
  • KPI/Quality Metrics Implementation​
  • Sterility Assurance​
  • Technology Transfer​
  • Validation Support (analytical, cleaning, process)​
  • Auditing & Due Diligence​
  • Risk Management Implementation​
  • Supplier Management & Monitoring Strategies​
  • Training​
  • Data Integrity ​
  • Computerized System Valdiation (CSV)​

GCP​

  • Auditing​
  • SOPs/Policies Development (issuing, review)​
  • Clinical trial study design/review: determination of sample size, blind study setup, randomization, choice of control product.​
  • Quality check.​
  • Quality System GAP Analysis vs regulations​
  • Data Integrity & Compliance Assessments​
  • Clinical Process Mapping​
  • CSV, Data Migration Plan & Data Quality Control​
  • Inspection Readiness​
  • CAPA Definition and Implementation​
  • Archiving Requirements for Study Documents​
  • Due Diligence​
  • Clinical Study Set Up​
  • QA Services & Training​
  • Compliance verification for clinical sites involved in Bioequivalence Studies​
  • Risk Analysis for Clinical Audit Planning​
  • Risk Analysis model definition for clinical trials​
  • Vendors | CROs selection​

GLP​

  • Facility Assessment & Audit​
  • GLP Remediation Plan & Execution​
  • Documentation Redaction Support​
  • GLP Study Monitor​
  • Study Audit​
  • GLP QA Support​
  • GLP Training​
  • First Certification Support​

Feed supplements​

  • Compound feed labelling check/development: composition, analytical constituents, instruction for use & claim.​
  • Substantation dossier for Coumpounf feed claims.​
  • New particular nutritional purposes dossier and application (PARNUT dossier).​
  • Feed additives dossier and applciation for registration, renewal & species extension.​
  • EURL and EFSA follow-up management.​
  • Feed materials, Feed additives and Premixture labelling.​
  • Feed Business Operator registration/approval processes.​
  • Regulatory intelligence​
  • Regulatory compliance ​

Bring your product into the next generation.

Contact our team for a first consultancy call.

ISO 9001 Certified compliance services provider since 1998.

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