Scientific Support
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
- 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
- info@altiex.com
