RISE supports the development of small molecules and biologics, from discovery to finished products. Our multidisciplinary teams provide characterization, formulation, functional assessment and regulatory guidance to help you move projects forward with confidence.
RISE drives the development of pharmaceuticals forward through research and development projects. Solutions that balance life-saving innovation with climate change are created through new formulation methods, ATMP processes, green chemistry and sustainable production.
From molecular design and formulation to GMP production and regulatory support, RISE offers services that support drug development throughout the entire chain. We act as an external R&D unit for companies that lack internal capacity or expertise.
In our GMP laboratories, we produce materials for clinical studies. We perform preclinical safety studies and toxicological analyses through GLP accreditation.
Developing medicines is a long and risky journey. Many promising compounds fail along the way due to lack of efficacy, safety issues, complex regulatory requirements, or simply insufficient funding.
At RISE, all expertise is gathered under one roof, making it possible to advance projects across different types of APIs, whether it is biologics or small-molecule drugs. Within biologics, including vaccines, antibodies, mRNA, and cell and gene therapies, we focus on formulation, stability, and immunological properties to ensure the API performs as intended. For small-molecule drugs, we ensure robust synthetic routes, high purity, and reproducibility, including safe handling of highly potent APIs (HPAPIs) when required.
Sustainability and regulatory compliance are integrated throughout the process, and we also support companies in navigating opportunities for public funding.
Drug development is fraught with risk: unexpected toxicity, unstable compounds, and poorly characterized molecules can delay projects or halt them entirely. RISE provides integrated analytics for small molecules and biologics, reducing risk and accelerating preclinical readiness.
At RISE, we provide integrated analytical support for small molecules and biologics, ensuring compounds are well-characterized, stable, and preclinically ready. By combining chemistry, bioanalysis, formulation, and GMP-ready quality control, we reduce development risk and accelerate timelines.
Our modular approach allows you to select individual services - such as solid-state screening, structure elucidation, or bioanalysis - or engage a full analytical program that supports your candidate through early GMP supply.
RISE delivers tailored analytical support for small-molecule drug candidates, covering identity confirmation, purity assessment, and solid-state characterization. Our integrated approach ensures reliable data, regulatory alignment, and preclinical readiness.
We design and validate analytical methods for identity, purity, and physicochemical profiling according to ICH Q2(R2) guidelines and aligned with EMA and FDA expectations. Methods are suitable for GLP- and GCP-compliant preclinical studies, ensuring data accuracy and regulatory readiness. Early GMP-aligned quality control ensures materials are fit for downstream development.
Molecular structure insight is critical. Our team applies NMR, LC/GC-MS, IR, and UV/VIS spectroscopy to confirm identity, determine purity, stability, and content, and support informed decision-making throughout development.
Solid-state properties impact manufacturability and formulation. RISE offers XRPD, DSC, TGA, particle size analysis, porosity and hygroscopicity studies, as well as salt/co-crystal screening, crystallization optimization, and scale-up troubleshooting. Early solid-state insight reduces downstream risk and enables robust, scalable processes.
We provide quantitative and qualitative bioanalysis of small molecules in complex biological matrices to support preclinical pharmacology and toxicology studies, including GLP-compliant work. Sensitive and accurate assays allow confident PK/TK interpretation, supporting early candidate evaluation and regulatory submissions.
RISE provides comprehensive analytics for biologics, including structural integrity assessment, aggregation profiling, and bioanalytical evaluation. Our methods support early decision-making, formulation readiness, and seamless transfer to GMP-compliant clinical-scale production.
We apply a broad suite of analytical techniques for proteins, antibodies, oligonucleotides, and other biologics, including LC-MS/MS, SEC, RP/IEX chromatography, SDS-PAGE, peptide mapping, spectrophotometry, and ELISA. These analyses provide detailed insight into identity, purity, structural integrity, aggregation, heterogeneity, and post-translational modifications.
We develop and validate robust bioanalytical methods, including GLP-compliant approaches, supporting early-phase evaluation and regulatory requirements.
RISE integrates analytical and formulation strategies designed for transfer to GMP-compliant clinical production. This approach enables early, data-driven decisions, mitigates risk, and accelerates the progression of candidates from discovery to preclinical studies.
RISE combines deep scientific understanding with advanced analytical, bioanalytical, and formulation expertise to ensure small molecules and biologics are fully characterized, stable, and preclinically ready. Our integrated approach supports the transition from early candidate evaluation to robust, GMP-compliant material for preclinical and clinical studies, including safe handling of high-potency APIs (HPAPIs) and complex biologics.
We operate under ISO 17025 accreditation and follow GMP, GLP, and EMA/FDA guidelines to ensure quality, reliability, and regulatory compliance at every step.
Our services range from targeted analyses and short feasibility studies to comprehensive, end-to-end analytical programs. Smaller companies gain access to specialized expertise and advanced infrastructure, while larger organizations can supplement internal teams with specific know-how or additional capacity as needed.
Need support with analytical characterization, bioanalysis, or preparation of clinical material? Get in touch to see how RISE can contribute expertise, infrastructure, and solutions tailored to your development program.
Our work combines advanced analytical techniques with internationally recognized standards to ensure reliable, regulatory-compliant results.
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.
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.
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.
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.
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.
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.
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.
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.
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.
High-resolution mass spectrometry, ion mobility, and nanoparticle/formulation analysis ensure robust PK/TK data and quality for complex biologic molecules.
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.
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.
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.
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.
Our work combines advanced analytical techniques with internationally recognized standards to ensure reliable, regulatory-compliant results.
Predictive and computational approaches
Bioanalytical techniques
Safety testing and risk Evaluation
Quality and compliance standards
Developing small-molecule drug substances requires robust synthesis, scalable processes and regulatorily ready approaches. Early challenges such as solubility, stability and bioavailability must be addressed while navigating a complex regulatory landscape and increasing expectations for sustainable pharmaceutical manufacturing.
RISE delivers integrated chemistry, process development, analytical and GMP expertise to help pharma and biotech teams progress efficiently from early discovery to clinical-trial API supply. We support small-molecule developers with tailored solutions across route design, process optimisation, solid-state chemistry, analytical characterisation and GMP-compliant production.
From early feasibility to clinical-trial material, we provide data-driven insights, scalable manufacturing strategies and, where required, the safe handling of highly potent active pharmaceutical ingredients (HPAPIs) under strictly controlled conditions. This enables robust development paths that reduce risk and accelerate timelines.
We support robust and scalable API development through structured process design, regulatorily aligned CMC strategies and GMP-compliant manufacturing, including safe handling of high-potency compounds where required. Explore our offer in more detail or contact us directly to discuss how we can address your challenges.
Ready to develop your next pharmaceutical product with us? Reach out and we’ll get back to you shortly.
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Developing small-molecule drug substances requires robust chemistry, scalable processes, and early regulatory alignment. Wrong decisions at this stage often lead to late redesigns, increased costs, and delays before clinical trials.
Taking a drug substance from early discovery to clinical trials is a complex journey with many risks. We help you build the right foundation from the start, with development that is scalable, safe, and aligned with future regulatory requirements. Our support spans the entire early lifecycle – from optimization and scale-up to quality assurance and clinical phase preparation. By combining chemical and process engineering expertise with deep CMC understanding, we create solid decision-making data and a smooth path toward clinical development.
Explore our offering or contact us directly for a consultation.
RISE designs and optimizes scalable synthetic routes for complex small-molecule APIs and building blocks. Our chemists combine both experience from academia and industry with AI/ML-assisted route scouting, and analytical capability to deliver efficient, robust, and industrially-relevant processes. This includes literature review, route identification, process development and early techno-economic assessment to support strategic decision-making.
We enable scale-up from laboratory to pilot scale through both batch and continuous processes, crystallization and advanced separation technologies. Our facilities accommodate small-volume, high-complexity work as well as pilot-scale production up to approximately 100 liters. Development emphasizes chemical hazard assessment, reproducibility, environmental impact and alignment with future GMP manufacturing and regulatory expectations.
Solid state and crystal form are often critical determinants of stability, processability, and clinical quality. RISE provides solid-state characterization and the design of robust crystallization processes for small-molecule drug substances.
We work with polymorphism, salts, and co-crystals, as well as particle size, morphology, and hygroscopicity. Development is linked early to downstream filtration, drying, formulation, and scale-up to avoid late-stage CMC rework.
Analytical techniques include XRPD (powder and single-crystal), DSC, TGA, DVS, SEM, laser-based particle size analysis, and surface area and porosity measurements.
Safe development is ensured through systematic evaluation of reaction hazards, byproduct risks and process safety for all chemistries, including HPAPI and high-hazard intermediates. We provide kinetic studies, and detailed safety data to support scalable, compliant and safe manufacturing. Risk mitigation is embedded from early route design through process validation.
Our CMC support spans synthesis route design, impurity profiling, process validation, analytical method development and transfer, crystallization and solid-state studies, techno-economic analysis and scale-up planning. Hazard and safety evaluations are performed for intermediates and HPAPI to ensure safe, reproducible and regulatorily-aligned manufacturing that can transition into GMP production.
RISE provides GMP-compliant pilot and small-scale manufacturing of active pharmaceutical ingredients for preclinical and clinical studies. This includes production of APIs and intermediates with safe handling of HPAPI, analytical method development, validation, in-process monitoring and documentation to support regulatory submissions. Our integrated development-to-manufacturing workflow ensures traceable quality control and efficient progression toward clinical trial delivery.
We utilize process analytical technology (UV-VIS, IR, NIR, RAMAN, FBRM), automated data acquisition systems and real-time monitoring. These tools accelerate optimization, increase reproducibility and facilitate data-driven process control. AI/ML-based route scouting further strengthens decision-making and enhances efficiency in both early development and scale-up.
RISE combines deep scientific expertise in chemistry and process development with advanced technical infrastructure to deliver integrated, scalable solutions ready for regulatory requirements. We support the entire journey – from route design and process optimization to solid-state characterization and GMP-compliant API manufacturing – enabling you to manage complex challenges with one trusted partner.
We operate under ISO 17025 accreditation and follow GMP, GLP, and EMA/FDA guidelines to ensure quality and compliance at every step.
Our services range from targeted analyses and short feasibility studies to full-scale development programs. Smaller companies gain access to specialist expertise and infrastructure, while larger organizations can strengthen their teams with specific know-how or additional capacity when needed.
Need support in early development or scale-up? Get in touch to learn how we can help with expertise, infrastructure, and solutions tailored to your project.
Identity & purity
NMR, LC–MS/MS, GC–MS, IR, UV/VIS. Ensures molecular structure and purity according to ICH Q2(R2).
Impurity profiling
LC–MS/MS, GC–MS. Identifies and quantifies impurities in line with ICH Q3A/B and ICH M7.
Solid state / crystal form
XRPD, DSC, TGA, DVS, SEM, particle size analysis. Characterizes polymorphism, crystal form, and hygroscopicity.
Formulation & particle analysis
Particle size, morphology, porosity, surface area. Provides insight into manufacturability and bioavailability.
Analytical method development & validation
HPLC/UHPLC, LC–MS/MS, GC–MS. Development and validation of quantitative methods according to ICH Q2(R2) and EMA/FDA guidelines.
Process analytical technology (PAT)
UV–VIS, IR, NIR, Raman, FBRM, real-time monitoring. Supports process optimization and control under GMP/GLP.
PK/TK & bioanalysis
LC–MS/MS in biological matrices. Provides exposure and toxicokinetic data in compliance with GLP and regulatory guidelines.
In-silico risk models
QSAR/QSPR, ADME/Tox prediction. Early toxicological risk assessment and candidate prioritization.
Toxicology screening
Ames test and predictive toxicology. Evaluates safety of compounds and impurities in line with ICH M7.
