Validation of Diagnostic & Pharmaceutical Products
Development and validation of diagnostic and pharmaceutical products with absolute regulatory compliance.
What we deliver
We deliver molecular qualification, analytical-clinical studies and method validation for biotech products, IVDs and advanced therapies — from experimental design to the regulatory dossier.
- ICH Q2(R2) analytical validation
- Molecular method qualification
- Stability studies
- ANVISA / FDA / EMA dossiers
The full technical documentation lives on the dedicated landing page.
Case studies, timelines, markers, protocols and scope form.
Other services
Pre-Clinical Research
A reference in innovation for pre-clinical assays — everything your study needs in one place.
Cell Line Authentication
Precision and reliability for safe pre-clinical results — 16+ STR markers analyzed in 10 days.
Base for CROs
Add high-level R&D engineering and ANVISA/FDA infrastructure to your CRO's portfolio — with no fixed costs.
Women's Health
Molecular biology reference lab — HPV, STIs, gynecological health, fetal sexing and genetics, with nationwide logistics.