Consultancy for drug/MD/food development

Consultancy for drug/MD/food development
Product Description

Our expertise offered in regulatory submissions and knowledgeable strategic skills in planning non-clinical testing programmes can reduce attrition rate and speed up the process.

galileo research

  • IT
  • 2023
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation
Specifications
  • Model
    Regulatory support: (Common technical document module 2.4, 2.6, 4; toxicological and pharmacological expert reports; PDE reports; Biological Evaluation Plan and Report.

galileo research

  • IT
  • 2023
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation

More Products from galileo research (4)

  • Biocompatibility of Medical Devices according to ISO 10993-1 series

    Product Biocompatibility of Medical Devices according to ISO 10993-1 series

    Galileo Research can drive the nonclinical development of your medical device by preparing the Literature Report and the Biological Evaluation Plan (BEP) according to ISO 10993-1, performing additional tests, if needed, and releasing the Biological Evaluation Report (BER).

    All tests can be condu...
  • Drug efficacy, In vitro and in vivo studies

    Product Drug efficacy, In vitro and in vivo studies

    We offer a full range of studies and bioanalytical services, providing powerful tools and rigorous solutions for preclinical drug development of therapeutic candidates, advance lead compounds towards first-in- human trials, and support for ongoing clinical development
  • Drug safety, in vitro and In vivo studies

    Product Drug safety, in vitro and In vivo studies

    In support of human clinical trials and marketing authorization approval, Galileo Research offers a full battery of toxicity studies for the regulatory development of small drugs, as well as biologics and advanced therapies, in compliance with Good Laboratory Practice (GLP), ICH and OECD guidelines.

  • Food safety evaluation

    Product Food safety evaluation

    Potential benefits and safety of dietary supplements need to be assessed by scientifically validated means, in the context of Regulation (EC) 2015/2283 on novel foods. Toxicological data, including genotoxicity, information on absorption, distribution, metabolism and excretion (ADME) need to be collecte...

galileo research resources (1)