Scientific Support

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Scientific Support

We offer the following scientific support:

Non-Clinical and Clinical Studies Overviews

  • Specialised and comprehensive literature search to support non-clinical, or clinical issues
  • Non-clinical overviews and summaries (Modules 2.4/2.6)
  • Clinical overviews and summaries (Modules 2.5/2.7)
  • Compilation of Modules 4 and 5

Medical Affairs Documentation

  • Scientific advise on Pharmacology studies (PK and PD)
  • Scientific advice for Bioequivalence studies
  • Biowaivers for Bioequivalence studies
  • Preparation of investigational medicinal product dossiers (IMPD)
  • Investigator"s Brochure (IB)
  • Paediatric Investigation Plans (PIPs)


  • Quality documentation (Module 3 compilation)
  • Quality overall summaries (Module 2.3)
  • Preparation of active substance master files (ASMF)
  • Quality Management systems (GXPs): Expert advise, implementation, validation, audits and trainning

Toxicological Consultancy Services

  • Environmental Risk Assessments (Module 1.6)
  • Environmental Risk Assessments: Phase I Estimation of exposure, and Phase II: Environmental fate and effects analysis
  • Environmental Risk Analysis Report
  • Rationale for non providing a complete Environmental Risk Assessment
  • PDE (Permitted Daily Exposure) Reports
  • OEL (Occupational Exposure Limits) Reports
  • Health Vigilance Protocols
  • Scientific advise on toxicology issues, reports, inspections or audits prepared by toxicologists certified by AETOX, EUROTOX and ERT
  • Assessment on elemental impurities in compliance with current legislation (ICH Q3D)
  • Assessment on Mutagenic impurities, and potential carcinogenic risk in compliance with current legislation (ICH M7)
  • Toxicological assessment for reporting, identification and qualification of related impurities for antibiotics
  • Extractables and leachables risk analysis
  • Hazard Communication Standard: Safety Data Sheet
Reliable and comprehensive scientific support in terms of Medical, Quality, and Toxicology issues.
Registered Office
  • Nám. 14. října 2/1307
  • 150 00  Praha 5 
    Czech Republic
  • Tel: +420 222 351 874
  • Fax: +420 222 351 875