Contact person
Håkan Hollmark
Försäljning-och Marknadschef
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Drug safety assessment
Unexpected toxicity, insufficient exposure, or inadequate risk assessment are common reasons why drug development projects are delayed or halted. RISE helps you identify risks early, ensuring your project can proceed safely and efficiently.
RISE supports drug candidate development by identifying and managing safety risks at an early stage, before large investments in synthesis or process decisions lock the project. Our toxicologists use predictive and in-silico tools, such as QSAR and ADME/Tox modeling, to evaluate mutagenicity, organ toxicity, and off-target effects, enabling early prioritization and reducing late-stage issues.
We perform risk assessments, monitor and quality-assure studies, and deliver documentation compliant with EMA, FDA, and other regulatory authorities. The goal is simple: reduce risk, avoid late surprises, and keep development moving forward.
Toxicology and bioanalysis for small molecules
Predictive toxicology and early risk assessment
We use in-silico tools such as QSAR and ADME/Tox modeling to evaluate mutagenicity, organ toxicity, and off-target effects, enabling early prioritization and reducing late-stage risks.
Toxicology consulting and safety monitoring
RISE provides strategic and practical guidance for the safety assessment of drug candidates. We design tailored toxicology programs, coordinate in vivo and in vitro studies, ensure compliance with regulatory requirements, and guarantee high-quality data. We act as your “one point of contact” throughout the process, from early assessments to preparation for clinical trials.
Mutagenicity and impurity assessment (ICH M7 support)
RISE performs mutagenicity screening of drug substances and impurities using established methods, including bacterial reverse mutation assays (Ames test). The resulting data support early impurity safety evaluations in alignment with ICH M7 and regulatory expectations.
Safe handling of complex molecules
Our analytical and chemistry experts support the safe handling and detailed characterization of chemically complex or challenging compounds, including highly potent active pharmaceutical ingredients (HPAPIs). This enables controlled early-phase evaluation and informed risk management.
Bioanalytical support for exposure and PK/TK
We provide sensitive quantitative and qualitative analysis of drugs and metabolites in biological matrices to support pharmacokinetic (PK), toxicokinetic (TK) and exposure assessments. Bioanalytical methods are developed and validated for discovery and preclinical studies, including work conducted under GLP.
Toxicology and bioanalysis for biologics
Molecular integrity, aggregation, and stability risk
We assess key attributes such as aggregation, purity, degradation and molecular heterogeneity. These data support safety risk evaluation, immunogenicity considerations and decisions related to formulation and process development.
Bioanalytical quantification and exposure analysis
Using LC-MS/MS, ELISA and other ligand-binding or mass-spectrometry-based methods, we quantify biological drugs, metabolites and degradation products. The resulting data inform PK/TK assessments and support early preclinical safety evaluation.
Early safety screening with molecular and analytical data
By combining computational approaches with advanced analytical techniques, we predict degradation pathways, potential off-target interactions and material compatibility. This enables safer biologic design and risk mitigation before preclinical studies are initiated.
Advanced analytics and nanoparticle/formulation analysis
High-resolution mass spectrometry, ion mobility, and nanoparticle/formulation analysis ensure robust PK/TK data and quality for complex biologic molecules.
Analysis of proteins, enzymes and biologics
RISE provides strategic and experimental support for the analysis of proteins, enzymes, and biologic drugs. Early characterization is essential for stability, safety, and efficient development.
We use high-resolution mass spectrometry (LC-MS/MS), chromatography, electrophoresis, spectrophotometry, and ELISA to provide both qualitative and quantitative insights.
We can answer questions about protein integrity, activity, stability, post-translational modifications, and the presence of aggregates or other contaminants.
RISE also offers guidance to ensure compliance with regulatory requirements from EMA, FDA, and other authorities.
Why RISE for drug safety and bioanalysis?
RISE combines deep expertise in predictive toxicology, bioanalysis and regulatory strategy with advanced technical infrastructure to deliver integrated nonclinical safety solutions. We support the full nonclinical phase of development – from early risk assessment and impurity strategy to PK/TK bioanalysis and preclinical study design – through a single, coordinated partner.
Our laboratories operate under ISO/IEC 17025 accreditation, and our work follows GMP, GLP and EMA/FDA guidelines to ensure quality, traceability and regulatory compliance at every stage.
Flexible nonclinical safety support
Our services range from targeted computational assessments and individual safety studies to fully integrated nonclinical safety programs. Smaller companies gain access to specialist expertise and infrastructure, while larger organizations can complement internal teams with specific capabilities or additional capacity when needed.
Contact
Need support with early safety strategy, nonclinical study planning or regulatory documentation?
Contact RISE to discuss how our expertise, infrastructure and integrated approach can support your development program.
More information
Methods and standards we use
Our work combines advanced analytical techniques with internationally recognized standards to ensure reliable, regulatory-compliant results.
Predictive and computational approaches
- QSAR/QSPR modeling for early risk assessment
- AI/ML-driven toxicity prediction and exposure modeling
- Weight-of-evidence (WoE) and human equivalent dose (HED) calculations
Bioanalytical techniques
- LC‑MS/MS and GC‑MS for quantitative and qualitative analysis
- ELISA and ligand-binding assays for biologics
- Ion mobility and high-resolution mass spectrometry for complex molecules
Safety testing and risk Evaluation
- Mutagenicity screening (Ames test) aligned with ICH M7
- Impurity and excipient risk assessment using TTC/Cramer frameworks
- PK/TK analysis and non-compartmental modeling
Quality and compliance standards
- ISO/IEC 17025 accredited laboratories
- GMP, GLP, and EMA/FDA guidelines for nonclinical safety
- ISO 10993 and ISO 14971 for biologics and device-related safety
