RELIABLE & HIGH-QUALITY LABORATORY — GLP & ISO 17025

Laboratory Services (In Vitro & In Vivo Pre-Clinical Studies)

All in vitro and in vivo studies are executed strictly according to Good Laboratory Practice (GLP) standards, validated against international health directives and major Pharmacopoeias (EP, USP, JP).

PRE-CLINICAL CONTRACT RESEARCH PACKAGES

In Vitro & In Vivo Study Designs

IN VITRO INVESTIGATIONS (50 m² Cell Culture Lab)

In Vitro (Target-Specific Cell Line) Study Designs

Custom in vitro study design on product-specific model cell lines
In vitro bioactivity / specific activity assays
In vitro potency assays
In vitro cytotoxicity determinations

IN VIVO INVESTIGATIONS (Vivarium & Surgery Facility)

In Vivo (Rodent & Animal Model) Study Designs

Ethical committee dossier preparation and formal approval management
Post-approval in vivo pharmacokinetic & pharmacodynamic (PK/PD) studies
Post-approval in vivo toxicological assessments
Post-approval immunogenicity profiling

📋 International Regulatory & Pharmacopoeia (EP, USP, JP) Compliance

Every in vitro and in vivo analysis is conducted under strict GLP compliance, fully validated according to international regulations and pharmacopoeial monographs (EP, USP, JP), and delivered in rigorous audit-ready reports under absolute client confidentiality.

SECTOR-SPECIFIC TESTING SUITES

Specialized Testing for Pharma, Cosmetic & Medical Device Industries

01 / PHARMACEUTICAL SECTOR

Pharmaceutical Sector

Our primary mandate as Biogenuslab is to prepare compliant study protocols for GLP and non-GLP in vitro and in vivo research, secure required ethical committee permissions, and conduct pre-clinical evaluations.

We provide turn-key scientific advisory, experimental design, validation, and documentation services throughout biopharmaceutical and nanomedicine drug development.

02 / COSMETIC SECTOR

Cosmetic & Personal Care

Our laboratory designs and executes compliant GLP and non-GLP in vitro & in vivo testing packages for cosmetics, derma-cosmetics, and personal care products under formal ethical committee approval.

Safety, efficacy, bioactivity, cytotoxicity, and irritation profiles are reported under ISO 17025 and GLP benchmarks.

03 / MEDICAL DEVICE SECTOR

Medical Devices & Biocompatibility

Key biocompatibility testing programs conducted for medical devices and implantable biomaterials:

• Biocompatibility Evaluation Suite:

In vitro cytotoxicity testing (TS EN ISO 10993-5)
Tests for irritation and skin sensitization (TS EN ISO 10993-10)
Tests for systemic toxicity (TS EN ISO 10993-11)
Genotoxicity and carcinogenicity tests (TS EN ISO 10993-3)
Tests for local effects after implantation (TS EN ISO 10993-6)