Accelerating from the lab to the market
Strategic solutions for every stage of your preclinical development
EU Public Affairs: Europe-funded health projects
Procurement and management
Agile preclinical development from the laboratory bench to the global market
Strategic solutions for every stage of your preclinical development. Non-clinical studies
About AXELEROS
AXELEROS Preclinical Development streamlines the preclinical development process for pharmaceutical, medical device, chemical, and advanced technology companies across Europe.
Leveraging our deep expertise in regulatory affairs and scientific strategy, we deliver tailored partnership solutions that empower biotechs, SMEs, and research teams to accelerate the journey of their innovative therapies to market.
With over 20 years of experience in Preclinical Development and Global Regulatory Affairs, our team is driven by a passion for excellence and guided by a commitment to scientific rigor, safety, and compliance.
We help our clients ensure safety, efficacy, and innovation throughout the regulatory process — bridging the gap between the laboratory and the marketplace, turning scientific breakthroughs into real-world health impact.
Why Choose Us?
| Regulatory Expertise Proven track record representing clients before regulatory health agencies and enabling first-time human trials. |
Strategic Guidance Tailored solutions to optimize regulatory pathways while reducing development costs. |
| EU Public Affairs Expertise in European health sector regulations, funding, and compliance. |
Accelerated Success Streamlined regulatory strategies to help biotech companies bring treatments to market faster. |
Services
Regulatory strategy, nonclinical development, study oversight, and toxicology to move faster safely
What we do
- Regulatory strategy & roadmap: global submissions, health-authority interactions (FDA/EMA/NMPA/PMDA) and client representation; CRO selection and execution oversight.
- Nonclinical development: study design and placement for safety pharmacology, general toxicology, reprotox/developmental, genotoxicity, and NAMs; due-diligence reviews.
- Study oversight & QA/QC (GLP): monitoring, data integrity and vendor performance.
- Technical writing: eCTD modules, Investigator Brochures, Briefing Books, PIPs/PSPs, and dossiers.
- Toxicological Risk Assessments (TRAs): for devices/combination products and consumer health.
How we accelerate preclinical
- Custom regulatory roadmap aligned with your target markets
- Single point of contact to coordinate CROs and timelines
- Fit-for-purpose protocols to avoid rework and late findings
- Authoring of all regulatory deliverables for meetings and submissions
- Transparent study oversight (GLP/non-GLP) with QA/QC
- Clear, decision-ready reports for investors and partners
From small molecules and biologics to oligos, mAbs, RNA-based vaccines, medical devices and IVDs — we tailor plans to your modality and risk profile.
Contact
Let’s talk about your project. We’ll reply within 24–48 hours.
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