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Services

Project Management 
Scientific writing 
Safety Assessments

For in- and out-licensing of drug candidates, AlbaTox provides a thorough review of the nonclinical dossier for completeness, technical competence, scientific and regulatory content, and assessment of data gaps and any regulatory issues to support a strategy into early clinical trials.

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Project management tasks:

  • Study design and protocol development

  • CRO selection 

  • Study monitoring

  • Data and report review

 

Specialist in inhalation toxicology support:

  • aerosol development;

  • test article estimates;

  • aerosol monitoring.

 

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Extensive experience in authoring scientific reports and regulatory documents:

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  • Nonclinical module 2.4/2.6;

  • Nonclinical sections of Investigational Brochures (IB);

  • Nonclinical sections of Pre-IND application and NDA as well as for applications for EU Market Approval;

  • Briefing documents for various regulatory authorities.

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Experienced in providing the following nonclinical safety assessments:

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  • Permissible Daily Exposure (PDE)

  • Impurities assessments in line with ICH 3QA/B

  • Residual solvents assessment in line with ICH 3QC

  • Elemental impurities assessment ICH 3QD

  • Extractables and leachables in line with PQRI recommendations

  • Toxicological assessment of vaping liquid ingredients and emissions 

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