We are Accelera
Toxicology you can trust. Timelines you can count on.
Our Approach
01
We Learn Your Program
Your molecule, your timeline, your regulatory pathway. We map the full picture before a single study begins.
02
We Design Around Your Challenges
Our toxicologists co-develop the study plan with you, anticipating gaps and regulatory hurdles before they become costly delays.
03
You Receive Submission-Ready Data
Clean reports, on-schedule delivery, and a scientific team available to walk you through every finding.
A Legacy of Preclinical Excellence
Accelera builds on more than 60 years of pioneering pharmaceutical R&D, spanning groundbreaking oncology discoveries to today’s modern CRO services.
Farmitalia establishes the Nerviano research center, pioneering anthracyclines (e.g., doxorubicin/Adriamycin), transforming cancer treatment.
Farmitalia merges with Carlo Erba to form Farmitalia Carlo Erba (FICE), creating Europe’s leading oncology R&D hub.
Acquired by Kabi Pharmacia (later Pharmacia after 1995 Upjohn merger).
Pfizer acquires Pharmacia.
Pfizer spins off Nerviano operations; Nerviano Medical Sciences (NMS) is founded as an independent oncology-focused entity.
Accelera Srl becomes an independent CRO unit of NMS, offering third-party preclinical services built on decades of big-pharma expertise (Farmitalia → Pharmacia → Pfizer).
Served >300 global pharma/biotech companies in Europe, US and South Korea
Formed key partnerships (e.g., DNDi, Cellectis, Karolinska Institutet).
Delivers integrated, high-quality preclinical solutions: toxicology, IND-enabling packages, consultancy and regulatory support.
Today, Accelera combines a rich heritage of in-house innovation with agile, client-focused CRO capabilities, accelerating regulatory-ready drug development worldwide.
Located in Greater Milan, Italy
Prime accessibility:
~30 min to Malpensa Airport,
~40 min to Linate, direct highways & trains to Milan center.
Your gateway to Europe’s top life sciences network.
Integrity
Collaboration
Accountability
Focus on Results
The principles powering Accelera’s premium preclinical excellence — every day, for every partner.
Accelera's Commitments
Quality at Accelera means trustworthy science, ethical innovation, and sustainable value — every study, every partner.
Commitment to Quality
At Accelera, quality is non-negotiable. Rooted in decades of pharmaceutical excellence, we deliver reliable, regulatory-ready preclinical data that accelerates your drug development with confidence. Our approach integrates rigorous standards, ethical responsibility, and strong ESG principles.
- GLP-certified and AAALAC-accredited facilities, recognized by EMA, FDA, KFDA, and MHLW
- Full compliance with international guidelines for scientific integrity and data reliability
Animal Welfare & Alternative Methods
We strictly follow the 3Rs (Replacement, Reduction, Refinement), prioritizing animal welfare through enriched environments, minimized distress, and continuous protocol refinement. We actively invest in in vitro, in silico, PBPK modeling, and other non-animal alternatives to reduce reliance on animal models while ensuring robust, translatable results.
Ethics in Research
We conduct all studies with transparency, scientific rigor, and accountability. Ethical review, harm-benefit analysis, and unbiased reporting are mandatory, ensuring research is justified, fair, and compliant.
Corporate Responsibility
We foster an inclusive, supportive workplace with health promotion programs, talent development, and fair practices. Through strategic partnerships, we support global health equity, neglected diseases, and rare conditions.
Sustainability
We reduce environmental impact via energy-efficient operations, waste minimization, sustainable procurement, and digital/alternative-method adoption, aligning business success with planetary responsibility.
Frequently Asked Questions
What types of toxicology studies does Accelera offer?
We provide a comprehensive range of general toxicology studies, from non-GLP Dose Range Finding (DRF) to subchronic, chronic, and carcinogenicity studies. These cover pharmaceuticals (small molecules, biologics, vaccines), excipients, and other compounds, conducted in rodents and non-rodents via all major administration routes.
Are your toxicology studies GLP-compliant?
Yes — all regulated studies are fully compliant with GLP standards and international guidelines (OECD, ICH). Our facilities are GLP-certified and AAALAC-accredited, ensuring data reliability for global regulatory submissions.
How do you support IND/CTA-enabling packages?
We design and execute optimized, integrated toxicology packages, including general tox, safety pharmacology, genotoxicity, TK evaluation, and reproductive toxicology (DART). Our experienced toxicologists collaborate closely to identify risks early, determine NOAELs/safe starting doses, and prepare regulatory-ready documentation.
Do you work with biologics, advanced modalities, or cell therapies?
Absolutely. We have extensive experience with biologics, NBEs, biosimilars, oligonucleotides, and cell-based therapies — addressing unique challenges like immunogenicity, immune complex disease, and species selection.
What species and administration routes are available?
We support all standard species (rodents and non-rodents) and major routes (oral, intravenous, infusion, intrathecal, subcutaneous, etc.), with full TK/PK integration.
How do you incorporate the 3Rs and alternative methods?
We strictly adhere to Replacement, Reduction, and Refinement principles, investing in in vitro, in silico, and other non-animal approaches to minimize animal use while maintaining robust, translatable data.
Can Accelera provide regulatory consulting alongside toxicology?
Yes — our team offers strategic advice, regulatory strategy development, agency interactions, and documentation support to navigate evolving global requirements.
How long do toxicology studies typically take, and what influences timelines?
Timelines vary by study type (e.g., acute vs. chronic), species, and complexity. We provide realistic estimates upfront and prioritize efficient execution without compromising quality — contact us for a tailored proposal.
How do I request a quote or discuss a project?
Simply reach out via our website contact form, email (info@accelera.org). Our experts are ready to discuss your needs, arrange visits, and deliver a customized proposal.
Why choose Accelera for toxicology?
With over 60 years of heritage at the Nerviano site, deep big-pharma expertise (Farmitalia → Pfizer → NMS), and a track record serving >300 global clients, we combine scientific rigor, proactive collaboration, and on-time delivery to de-risk your pipeline and accelerate success.
Why should a small biotech company choose Accelera over larger or other CROs?
Accelera combines decades of high-level big-pharma expertise with the flexibility and personalized attention small biotechs need. We offer customer-tailored services, close scientific collaboration, and cost-effective, optimized programs, without the bureaucracy of mega-CROs. Our track record includes serving >300 global pharma and biotech clients, with a strong emphasis on startups, academics, and emerging companies.
How does Accelera prioritize small biotech and startup clients?
Small biotech and startups are a core priority for us. We provide flexible, integrated solutions, from proof-of-concept to full IND-enabling packages, designed specifically for resource-constrained innovators. Our teams work side-by-side with yours to address unique challenges (e.g., novel modalities like cell therapies, biosimilars, or oligonucleotides), proactively solve issues, and maximize value from limited budgets and timelines.
What advantages does Accelera offer for emerging companies with limited resources?
- Tailored, efficient programs — Customized IND/CTA packages, non-GLP DRF to GLP chronic tox, and integrated ADME/TK — helping you advance candidates faster and smarter.
- Proactive partnership — Scientists collaborate directly to identify risks early, refine designs, and avoid costly delays.
- Regulatory-ready quality — GLP/AAALAC-accredited, with data accepted by EMA, FDA, KFDA, MHLW — giving small teams confidence in submissions.
Can Accelera handle the unique needs of small biotech pipelines (e.g., novel modalities or tight cash runways)?
Yes, we specialize in supporting innovative pipelines with limited internal infrastructure. Our agile approach includes high-throughput profiling, in silico predictions, alternative methods (3Rs focus), and strategic consulting to stretch resources, de-risk decisions, and extend runways while delivering high-quality, translatable data.
Partner with Accelera’s Scientific Team
Let’s discuss how our preclinical toxicology and safety expertise can accelerate your drug development program.