Build a stronger development pathway with integrated nonclinical safety expertise.
Accelera provides comprehensive scientific and technical support to advance your compound from early development through Marketing Authorization Application. Our integrated services are designed to de-risk development, streamline decision-making, and meet regulatory expectations across global markets.
Discovery
Successful drug discovery requires early insight into safety, efficacy, and translational relevance.
At Accelera, we partner with sponsors from the earliest development stages to generate robust data that reduce uncertainty and support decision making well before regulatory milestones.
Our science-driven discovery services are designed to proactively de-risk candidates and support confident progression. By integrating exploratory in vivo studies, mechanistic investigations, target safety assessments, and translational biomarker strategies, we provide a coherent framework for informed candidate selection across small molecules, biologics, and advanced modalities.
With flexible study designs and efficient execution, our experienced scientific leadership team responds seamlessly to evolving program needs while maintaining the highest scientific standards.
Target Safety Assessment
Target properties are integral to drug development projects. Some of them can result in safety risk. Our Target Safety Assessment service offers a structured, expert evaluation of the biological safety profile of drug targets early in the discovery process. By combining literature review, genetic and pathway analysis, expression profiling, and translational insight, we identify potential safety risks linked to target biology before they impact program progression.
This results in informed decision-making, improved regulatory positioning, and reduced late-stage attrition.
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In Vitro Toxicity
Accelera provides integrated in vitro toxicology services to generate early mechanistic insight and support compound prioritization during discovery. Our capabilities include cytotoxicity screening, exploratory genotoxicity assays, embryotoxicity models, and phototoxicity testing, enabling early identification of potential safety risks prior to in vivo development.
These studies facilitate rapid hazard detection, inform biomarkers and endpoint selection for subsequent in vivo investigations, and strengthen weight-of-evidence safety strategies before entry into regulated programs.
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Exploratory toxicity studies
Accelera conducts flexible exploratory studies designed to proactively identify potential safety risks and support informed decision-making prior to GLP programs. Beyond traditional MTD or dose range-finding evaluations, our de-risking approach can incorporate cardiovascular assessments, informative PK/PD investigations, and other tailored endpoints aligned with the compound’s mechanism of action.
Leveraging multidisciplinary expertise and adaptive study designs, we generate early, decision-enabling data that refine dose selection, anticipate liabilities, and strengthen the scientific foundation of subsequent regulatory studies.
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Early Formulation
Accelera provides early formulation support to enable reliable dosing and enhanced exposure and optimal tolerability in non-clinical studies. Our scientists develop fit-for-purpose formulations tailored to the physicochemical properties of each compound and aligned with specific study objectives, with a focus on maximizing bioavailability while minimizing compound usage. Our capabilities include development of solutions and suspensions across multiple routes of administration, vehicle selection for in vitro and in vivo studies, and customized strategies to address solubility and stability challenges early in development. By optimizing formulation performance from the outset, we support consistent dosing, optimized exposure, and seamless progression into toxicology and IND-enabling programs.
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Efficacy Models
Accelera offers a comprehensive and validated portfolio of in vivo efficacy models designed to accelerate oncology drug development and generate decision-enabling data across discovery and preclinical stages. Our platforms span cell line-derived xenografts (CDX), syngeneic and humanized systems, orthotopic and bioluminescent models, as well as genetically engineered mouse strains, enabling tailored study designs aligned with each compound’s mechanism of action.
Leveraging over 50 validated tumor models and multidisciplinary scientific expertise, we support the evaluation of tumor growth inhibition, metastatic progression, and combination strategies in clinically relevant settings. From rapid screening to advanced translational models, our integrated approach delivers robust, high-quality data that strengthens program confidence, de-risks development, and supports informed progression toward regulatory milestones.
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Biomarkers
Accelera provides biomarker analysis services to support translational interpretation of non-clinical studies and mechanism-based evaluation of drug candidates. Using validated ELISA and multiplex immunoassay platforms, we enable sensitive detection of multiple biomarkers from limited sample volumes across different species and study types.
Biomarker results are integrated with complementary endpoints—such as cytokine profiling, immunophenotyping, and clinical pathology—to enhance the interpretation of pharmacological and toxicological findings. This approach supports early identification of biological signals and strengthens the translational value of preclinical data.
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IND-Enabling
As development progresses, Accelera supports sponsors in building IND-enabling non-clinical packages aligned with global regulatory expectations.
Our multidisciplinary teams bring extensive experience supporting successful IND submissions across a broad range of therapeutic areas and drug modalities, including small molecules, biologics, and advanced therapies.
Through coordinated study strategies, strong scientific oversight, and regulatory insight, we generate reliable, submission-ready data that enable confident progression into first-in-human studies.
Short-Mid Term Toxicity Studies
Accelera is a trusted partner for comprehensive general toxicology services supporting IND /CTA enabling programs. We design and conduct high quality, GLP-compliant studies in rodent and non-rodent species, addressing systemic toxicity, target organ identification, and dose selection to support global regulatory requirements.
With proven expertise across small molecules, biologics, and advanced therapies, our experienced scientific teams provide submission ready data that enable confident progression from preclinical development to clinical trials.
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Formulation Development
Accelera integrates robust analytical capabilities to ensure formulation quality, stability, and regulatory compliance throughout non-clinical development. Our teams develop and validate analytical methods (HPLC-UV, UV-Vis) to support concentration verification, homogeneity assessment, solubility characterization, and dose formulation stability under GLP conditions.
Through robust analytical methodologies and rigorous quality systems, we generate reliable, reproducible data that confirm formulation integrity during dosing periods. This integrated approach strengthens data interpretability and supports regulatory-ready toxicology and pharmacology programs.
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Safety Pharmacology
Accelera provides IND-enabling safety pharmacology services to evaluate the potential impact of investigational products on vital physiological systems, supporting early identification of pharmacodynamic liabilities prior to clinical development. Our integrated approach combined validated in vitro and in vivo models, advanced telemetry platforms, and expert interpretation to support risk assessment and clinical dose selection.
Conducted as standalone studies or integrated within broader toxicology programs, our assessments are aligned with global regulatory expectations and provide robust data on core battery organs (cardiovascular, pulmonary and nervous system, among others).
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Genetic Toxicology
Our Genetic Toxicology services evaluate mutagenic and clastogenic risk in support of early development according to global regulatory requirements. We deliver a full range of screening and OECD/ICH-compliant studies, combining in vitro and in vivo approaches to assess DNA damage, gene mutations, and chromosomal alterations.
Backed by decades of scientific expertise and full GLP compliance, we support pharmaceutical, biotech, and chemical programs.
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Special Investigations
Accelera provides tailored special investigations to address specific safety questions that emerge during non-clinical development.
Local Tolerance
Our local tolerance assessments are designed to evaluate site-specific reactions across a range of administration routes, ensuring accurate characterization of irritative, inflammatory, or degenerative changes at the dosing site.
Through clinical observation and expert histopathological evaluation, we distinguish procedure-related findings from compound-related effects and assess potential reversibility.
Advanced Therapies: Cell & Gene Therapy
Accelera supports the non-clinical development of cell-based and gene therapy products through tailored safety and translational programs designed to address the unique complexity of these modalities. We develop bespoke preclinical strategies to evaluate biodistribution, persistence, genomic integration, tumorigenicity, and potential off-target effects prior to clinical entry.
Our specialized studies combine molecular techniques and detailed histopathological evaluation to characterize tissue distribution, long-term persistence, as well as tumorigenicity evaluations to characterize oncogenic risk and uncontrolled proliferation potential.
By integrating advanced in vitro and in vivo models with strong regulatory expertise, we generate scientifically robust, risk-focused data packages designed to address the unique scientific and safety challenges of these modalities.
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Post-IND
Beyond IND submission, Accelera continues to support sponsors through the later stages of development, delivering long-term safety programs and specialized studies required for global marketing authorization.
From carcinogenicity and juvenile toxicology to targeted mechanistic investigations, our teams provide the scientific expertise and operational strength needed to advance therapies confidently toward NDA and MAA approval.
Long Term Repeated Toxicity Studies
Accelera supports long-term toxicology programs required during later stages of development and for global marketing authorization. These studies are designed to evaluate chronic toxicity, characterize long-term safety profiles, and support regulatory submissions across major health authorities.
Long-duration studies often involve significant scientific and operational complexity, requiring careful planning, consistent oversight, and coordinated multidisciplinary expertise. Our teams are experienced in managing these demanding programs, including study designs that may integrate additional assessments such as fertility or genotoxicity endpoints where appropriate.
Leveraging strong operational experience and multidisciplinary scientific expertise, we deliver high-quality, GLP-compliant data that ensure continuity of non-clinical safety evaluation throughout the product lifecycle.
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DART Studies
Accelera offers full-scope Developmental and Reproductive Toxicology (DART) programs to support global regulatory submissions, backed by decades of scientific expertise and a strong regulatory foundation. Since 2010, we have completed more than 100 GLP-compliant studies assessing fertility, embryo-fetal, and pre/post-natal development in accordance with international guidelines.
Our team includes study directors registered with the International Register of Fetal Morphologists (Royal Society of Biology), bringing over 30 years of hands-on DART experience. Through scientifically rigorous design, precise execution, and expert evaluation, we deliver ICH S5(R3)-aligned in vitro and in vivo programs across small molecules, biologics, and advanced modalities—supporting robust reproductive risk assessment and confident clinical advancement.
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Juvenile Studies / Pediatric Drug Development
Accelera provides specialized juvenile toxicology services to support pediatric drug development programs in accordance with EMA and FDA requirements. We design age-appropriate, scientifically robust studies in relevant species to evaluate growth, organ maturation, neurobehavioral development, and reproductive function.
Building on extensive expertise in reproductive and general toxicology, we ensure precise dose selection, optimized study timing, and scientifically based endpoints tailored to the specific characteristics of each compound. Functional and behavioral assessments as well as TK endpoints are routinely integrated, which provides an exceptional quality standard of data and ties in seamlessly with broader non-clinical development programs.
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Carcinogenicity Studies
Accelera provides strategic carcinogenicity assessment services aligned with the evolving global regulatory expectations (ICH S1A–S1C and the ICH S1B(R1) weight-of-evidence framework). We support sponsors in defining the most appropriate development strategy including waiver applications, studies in genetically modified animals, and classic 2-year bioassays.
Our robust, GLP-compliant carcinogenicity studies industry leading pathology and data interpretation teams.
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Immunotoxicity Studies
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Frequently Asked Questions
At what stage of drug development can Accelera support my program?
What types of drug modalities do you work with?
Our services cover a broad spectrum of therapeutic modalities, including small molecules, biologics, and advanced therapies such as cell and gene therapy products. We have dedicated expertise for each category, with study protocols and scientific strategies adapted to their specific preclinical and regulatory requirements.
How can Accelera help reduce attrition of my drug candidate in early development?
Through our Discovery services — including Target Safety Assessment, in vitro toxicity studies, exploratory in vivo studies, and biomarker analysis — we generate early, decision-enabling data that identify safety liabilities before significant resources are committed to GLP programs. Our integrated de-risking approach is designed to support scientifically informed candidate selection and confident progression.
Are your studies conducted under GLP compliance, and for which regulatory authorities?
Yes. All IND-enabling and post-IND studies at Accelera are conducted in full GLP compliance and designed to meet the regulatory expectations of major international health authorities, including the FDA, EMA, and others. Our study designs are aligned with applicable ICH and OECD guidelines to ensure global regulatory acceptability.
Can you support the complete non-clinical package for an IND or CTA submission?
Yes. Our multidisciplinary teams have extensive experience supporting successful IND and CTA submissions across a wide range of therapeutic areas and drug modalities. We coordinate integrated study strategies — spanning general toxicology, safety pharmacology, genetic toxicology, and analytical formulation — to generate a robust, submission-ready data package that enables confident progression into first-in-human clinical trials.
What is your experience in DART studies and reproductive toxicology?
Accelera has over 30 years of hands-on expertise in Developmental and Reproductive Toxicology (DART) and juvenile toxicology studies. Since 2010, we have completed more than 100 GLP-compliant studies evaluating fertility, embryo-fetal development, and pre/postnatal development in accordance with ICH S5(R3) guidelines. Our team includes Study Directors registered with the International Register of Fetal Morphologists (Royal Society of Biology).
What non-clinical services do you provide for advanced therapies such as cell and gene therapy?
We develop bespoke non-clinical strategies for cell-based and gene therapy products, addressing the unique scientific and regulatory complexity of these modalities. Our programs include assessments of biodistribution, persistence, genomic integration, tumorigenicity, and potential off-target effects, combining advanced molecular techniques with expert histopathological evaluation to generate risk-focused, regulatory-ready data packages.
How do I get started with Accelera for my drug development program?
The first step is to reach out to our scientific team for a strategic consultation. We provide expert regulatory and scientific advice to help you define a tailored, cost-effective development pathway with strong regulatory acceptability. Contact us through the form on our website and one of our specialists will be in touch to discuss your program’s specific needs.
Partner with Accelera’s Scientific Team
Let’s discuss how our preclinical toxicology and safety expertise can accelerate your drug development program.