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Regulatory & Preclinical Solutions

Regulatory

AXELEROS Preclinical Development is your preclinical development expert partner specializing in Regulatory Strategy, offering tailored solutions to navigate the complex regulatory landscape of the life sciences industry. Our expertise ensures that your products meet the necessary regulations and policy standards while reducing project costs and accelerating timelines.

 

 Regulatory Offering:

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  • Custom-made regulatory roadmap and execution, including CRO selection

  • Global regulatory submissions to major national health regulatory agencies

  • Regulatory interactions and client representation, including to FDA, EMA, NMPA, PMDA

  • In vivo and in vitro study oversight and QA/QC management (GLP)

  • Technical writing and documentation (eCTD modules, Investigator Brochures, Briefing documents, PIPs/PSPs, among others)

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Nonclinical Drug Development

Our Nonclinical Drug Development services are designed to support the preclinical testing and development of small molecules, biologics, biosimilars, oligos, peptides, mAbs, RNA-based vaccines, medical devices, in vitro diagnostics, genomics, proteomics, and consumer products, including cosmetics. Our regulatory and policy experts provide strategic regulatory guidance and sound scientific planning and execution to streamline the pre-clinical safety testing of product development to ensure safety and efficacy. 

 

Competencies include placement and management of preclinical safety studies (GLP and non-GLP):

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  • Safety pharmacology​ studies

  • General toxicology studies 

  • Reproductive and developmental toxicology

  • Genotoxicity

  • Alternative Methods (NAMs)

  • Study oversight and monitoring

  • Due diligence evaluations
     

Toxicological Risk Assessments (TRAs)

At AXELEROS, we conduct comprehensive Toxicological Risk Assessments to evaluate the potential risks associated with exposure to hazardous substances. Our assessments help clients make informed decisions to ensure the safety of their products and protect public health.

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•  â€‹â€‹Hazard Identification

•  Exposure Assessment

•  Risk Characterization

•  Regulatory Compliance​

EU Public Affairs

AXELEROS Preclinical Development is proud to participate in and guide our clients through the complexities of European-funded health projects. Our expertise helps unlock valuable partnering and funding opportunities, accelerating the development of innovative healthcare solutions.

 

Partner with us to make a real impact on healthcare across Europe!

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