Contact person
Håkan Hollmark
Försäljning-och Marknadschef
Contact HåkanDrug safety and bioanalysis for small molecules and biologics
Safety-related findings remain one of the most common reasons for costly delays in drug development programs. Unanticipated toxicity, reactive impurities or uncertain exposure profiles can fundamentally alter development trajectories long before a compound reaches the clinic. Robust, early nonclinical safety assessment is essential.
From early screening to regulatory submission
RISE acts as a nonclinical safety partner, supporting data-driven decision-making from early screening through regulatory submission. Whether you are developing small molecules, biologics or emerging modalities, we design and coordinate integrated nonclinical safety programs that combine predictive toxicology, bioanalysis, impurity and excipient evaluation, and regulatory strategy.
We prepare and document risk assessments, manage and monitor nonclinical studies, and deliver regulatory-ready data packages aligned with EMA and FDA expectations. Our role is to help you identify and manage safety risks early, avoid late surprises, and progress confidently toward first-in-human studies.
Explore our modality-specific safety and bioanalysis services below, or contact us to discuss your development needs.
Toxicology and bioanalysis for small molecules
RISE supports the development of small-molecule drug candidates by identifying safety liabilities early, before synthesis scale-up and late-stage process decisions limit flexibility. Through predictive methods, targeted testing and bioanalytical support, we enable informed go/no-go decisions based on data rather than assumptions.
Predictive toxicology and early risk assessment
We apply in silico tools such as QSAR and ADME/Tox prediction to evaluate novel compounds prior to synthesis. These approaches are used to assess mutagenicity risk, off-target activity and potential organ toxicity, supporting early candidate prioritization and reducing the likelihood of late-stage attrition.
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
RISE evaluates safety-critical quality attributes for biological drug candidates, including proteins, peptides, oligonucleotides and other advanced modalities. Our work focuses on molecular integrity, stability, aggregation risk, exposure strategy and early factors that may influence immunogenicity and first-in-human risk.
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.
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
