Veterinary

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

Veterinary Services

Pharmacovigilance for Veterinary Medicinal Products
Regulatory Intelligence and Services for Veterinary Medicinal Product
Veterinary Medical Device Management
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

Your reliable partner
for Veterinary Healthcare

We support you in fostering excellence and innovation in veterinary pharmaceutical standards worldwide through our strategic partnership.

Why choose us?

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

Veterinary System Outsourcing

QPPV, deputy QPPV and Veterinary Surgeon
Complete PV Quality Management System (30 technical SOP and Quality Assurance SOP)
Pharmacovigilance Quality Assurance Services
Pharmacovigilance task management (SAE reports, signal management, benefit-risk balance monitoring, KPI)

Veterinary Pharmacovigilance Audit

Internal Audit (PV system, specific product)
Supplier Audit (Service Provider)
Third party Audit (Dealer, Vendor, Distributors, Local Representatives, Affiliates ..)

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