LabSense d.o.o. is a privately held contract laboratory. The company positions itself as an independent, customisation-focused contract laboratory combining advanced R&D, GMP-compliant analytical testing, and digital laboratory innovation to support pharmaceutical and biotechnology organisations across the drug development and quality control lifecycle.

The company holds GMP certification verified on the EMA EudraGMDP database, GLP certification, ISO 9001:2015 quality management certification, and ISO 27001 information security management certification — a robust compliance framework for a laboratory of its size that supports engagement with regulated pharmaceutical clients across the European market. Its ISO 27001 certification is particularly notable, reflecting a deliberate commitment to data security in laboratory information management that is increasingly relevant as clients digitalise their laboratory workflows.

LabSense’s service model is built around four pillars — Quality Control, Research and Development, Digital Lab Solutions, and Custom Workflows — with a stated emphasis on bespoke, client-specific solutions rather than standardised catalogue services. The company publishes a specialist blog covering nitrosamines, GMP quality control, and laboratory digitalisation, indicating active scientific engagement with the regulatory topics most relevant to its client base.

Key Products and Services

Quality Control

• Analytical Method Validation — definition and verification of method performance characteristics including linearity, accuracy, precision, specificity, LOD/LOQ, and robustness, conducted in line with ICH Q2(R2) and applicable pharmacopoeial requirements under GMP/GLP procedures
• Analytical Method Transfer — structured method transfer between laboratories using formal transfer protocols, comparative testing, and predefined acceptance criteria, with complete documentation suitable for regulatory submission
• QC Testing — routine quality control testing for pharmaceutical products, including release and stability testing, ensuring compliance with registered specifications and regulatory standards
• Stability Studies Support — design, execution, and reporting of stability studies to support shelf-life determination and regulatory submission, conducted under ICH-aligned stability storage conditions

Targeted Impurity Analysis

• Nitrosamine Analysis — validated LC-MS/MS methods for the detection and quantification of nitrosamine impurities at trace levels in pharmaceutical products, aligned with EMA and FDA nitrosamine guidelines; a specialist capability reflecting the global regulatory priority placed on nitrosamine control since 2018
• Benzene in Benzoyl Peroxide (BPO) Products — sensitive validated analytical methods for benzene quantification in BPO topical formulations, supporting recall risk management, safety decisions, and regulatory submissions in response to FDA and EMA scrutiny of benzene contamination in this product class

Research and Development

• R&D analytical services for pharmaceutical and biotechnology clients at the preclinical and development stages
• Custom method development for novel compounds, complex matrices, and emerging regulatory requirements

Digital Lab Solutions

• Laboratory digitalisation consulting and implementation — design and deployment of digital workflows, electronic laboratory notebooks (ELN), laboratory information management system (LIMS) integrations, and data integrity solutions for pharmaceutical laboratory environments
• Custom digital workflow development tailored to client-specific laboratory processes and regulatory compliance requirements

Custom Workflows

• Bespoke laboratory workflow design and execution for client-specific analytical, R&D, or quality system requirements that fall outside standard service categories

Industry Positioning

LabSense occupies a focused position in the Central and Eastern European pharmaceutical contract laboratory market as a GMP/GLP-certified independent analytical laboratory with a specialist emphasis on nitrosamine and benzene impurity analysis — a regulatory priority area that has generated sustained demand from European pharmaceutical manufacturers since EMA and FDA began issuing nitrosamine-related guidance and recalls from 2018 onwards. Its Croatian base provides a cost-competitive EU-member-state location with direct EMA GMP regulatory alignment, making it a credible and accessible laboratory partner for European pharmaceutical companies requiring GMP-compliant testing without the cost structures of Western European contract laboratories. The combination of traditional analytical testing services with an active digital lab solutions offering positions LabSense as a laboratory partner attentive to the ongoing digitalisation of pharmaceutical quality systems — a differentiation that may resonate with clients seeking a single partner for both analytical outsourcing and laboratory information management modernisation. As a recently established laboratory with a compact but well-credentialed compliance framework, its commercial scale and client portfolio remain developing.