SUPPORT FROM EARLY DISCOVERY STAGE TO CLINICAL TRIALS

  • Condensed experience for more than 30 years

  • Our experts understand and support every step of a Drug Development Program

    • Medicinal chemistry

    • Early screening

    • Target identification and validation

    • In vitro and in vivo pharmacology

    • ADME, Toxicology and safety pharmacology

    • Regulatory support

    • Clinicals trials

We know what you need – We deliver what we promise

Planning, securing and defending intellectual property is a challenge which every innovative life science company constantly faces during all stages of the product life cycle.

NeuroScios experts comprehensively analyze segments of the biomedical patent landscape for gaps that could be exploited in accordance with our customers' strategic objectives, conduct freedom-to-operate searches to identify interfering patents, and assist with the drafting of our customers' patent applications.

Medical writing accompanies a compound from the very first steps of drug development starting in the laboratory trough in vivo testing and toxicology, clinical trials till market release and during the whole lifetime of a drug.

 NeuroScios provides medical writing services for all stages.

  • Study protocols and reports (Phase I-IV)

  • Investigator brochures and annual updates

  • Informed consents

  • Translation of study documents from English to local languages and back

  • Data Safety Monitoring Board (DSMB) manuals 

  • Benefit risk assessment reports

  • Pre-clinical study reports, expert reports and summaries

  • Non-Clinical Safety

  • Periodic safety reports : DSUR

  • Experts opinion

  • Answers to queries from authorities

NeuroScios has accumulated considerable know-how in drug and medical device regulations.

Working at the complex interface between science, business planning, ethics committees, and government authorities, we provide expert strategic advice and can prepare regulatory documents for submissions to the European Medicines Agency and the U.S. Food and Drug Administration.

NeuroScios can plan and handle Scientific Advice procedures at the EMA and the FDA, during which regulators commit themselves to a framework of requirements on which developers can plan the regulatory effort.