Non-clinical toxicology(GLP)

A team of non-clinical scientists holding extensive expertise working in cutting-edge facilities

Regulatory-grade studies supporting human health, animal health, medical devices and bioactive products

Are you looking for a trusted GLP partner to generate robust non-clinical safety data for your product?

CER Groupe is GLP-certified by the Belgian Competent Authority (Sciensano) since 1993, with a dedicated GLP toxicology scope since 2010.

Key Figures

+400

Studies performed

1993

GLP-Certifed since 1993

8-12

Week to introduce a study

  • Full adherence to OECD Principles of Good Laboratory Practice
  • GLP scope covering toxicology, safety, residues and analytical chemistry testing
  • Strong scientific expertise (PhD- and MSc-level scientists)
  • End-to-end workflow: from study design to data archiving
  • Dedicated project management & transparent communication
  • Strong client loyalty and long-term partnerships

Regulatory-Ready Safety & Toxicology Studies

CER Groupe delivers Good Laboratory Practice (GLP)-compliant toxicology and safety studies. All in vivo toxicology studies are designed according to ICH, VICH, OECD and ISO guidance, with a strong focus on scientific relevance, animal welfare and regulatory acceptance. Study duration, dose levels, group size and endpoints are defined based on the intended clinical or regulatory use, ensuring data are both fit-for-purpose and inspection-ready.

Human medicinal products

  • IND-enabling and First-in-Human (FIH) programs
  • IMPD submissions (EU)
  • EMA / FDA non-clinical safety sections

Veterinary medicinal products

  • VICH guidelines (VICH GL, CVMP guidance)
  • EFSA and EMA CVMP requirements
  • Residue depletion and MRL support
  • Medical Device Biological Evaluation (ISO 10993 / EU MDR)

Novel Food, food ingredients, feed additives, pesticides, other crop solutions and bioactive substances for EFSA submissions

Our services cover the full workflow, from study design to final archiving, combining:

  • In vivo toxicology and safety studies
  • In vivo pharmacology, ADME and biodistribution

Scope of Toxicology & Safety Studies – Overview Table

We support you across the full non-clinical lifecycle:

Study design → protocol development → execution → QA & reporting → archiving

The table below summarizes all study types, combining transversal evaluations with item- and host-specific studies.

GLP Veterinary

CER Groupe conducts toxicology, safety and clinical studies for veterinary medicinal products, fully aligned with VICH and CVMP requirements.

Pharma & biotech

CER Groupe conducts toxicology, safety and PK/TK studies for human and animal health products, fully aligned with ICH guidelines.

Medical Device

CER Groupe supports medical device manufacturers with ISO 10993 biocompatibility studies for Class II and III devices under MDR.

Agrifood

CER Groupe supports agrifood, feed and crop developers with tailored toxicology and analytical studies, ensuring safety and regulatory acceptance.

In addition to animal studies, CER Groupe provides standalone GLP analytical services, supporting a wide range of regulatory contexts.
Analytical Method Development & Validation
  • Method development and full validation
  • Method transfer and verification
  • Stability studies
  • Routine GLP testing

Applicable to

  • Veterinary medicinal products
  • Crop protection products
  • Feed and food matrices
  • Environmental samples
  • Field trial samples
Metabolite Identification & Quantification
  • Metabolite profiling using advanced mass spectrometry
  • Parent compound and metabolite quantification
  • Support to metabolism, residue and environmental fat

Technologies

  • LC-MS/MS
  • HR-MS (high-resolution mass spectrometry)
  • Targeted and untargeted metabolomics approaches
Fully compliant with OECD GLP and regulatory guidance for metabolites in human, veterinary and agrifood contexts.

Animal Monitoring & Safety Endpoints

CER Groupe integrates comprehensive monitoring techniques adapted to your study objectives - ensuring early detection of adverse effects and reliable toxicological interpretation.

  • Clinical signs, behavior and welfare scoring
  • Body weight, food and water consumption
  • Cardiovascular and respiratory parameters
  • Neurological and locomotor activity endpoints
  • Blood pressure and physiological monitoring

These endpoints contribute to early detection of adverse effects, improved toxicological interpretation, and stronger benefit-risk assessment.

Your Deliverables at Every Step

Indicative timelines may vary depending on product type, study design, species and regulatory requirements

  • Before study start - complete study design with protocol, statistical considerations and GLP approval through an QA review
  • During study - regular project updates, early signal discussions when relevant, and deviation management under GLP
  • End of study - final GLP-compliant study report with Quality Assurance statement, raw data archiving under GLP, and data directly usable for regulatory submission
  • Early interaction allows timeline optimization and risk mitigation

8–12 weeks from study agreement to first dosing (GLP) - shorter timelines available for analytical-only or non-GLP exploratory studies.

Quality, Compliance & Workflow

  • GLP-compliant infrastructure with independent QA
  • Full workflow: from design to archives
  • Secure data management and long-term archiving
  • Inspection-ready processes

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