• Common Technical Documents (CTDs)

for new drug applications or label changes such as Rx to OTC-switches and type II variations in accordance with EudraLex Vol 2B of the European Commission (EC)

  • Briefing books

outlining the company’s relevant questions and positions in preparation of advisory meetings with the competent authorities according to the available guidance from the EMEA and the FDA

  • Labeling: Summary of Product Characteristics (SmPC),
    Core Data Sheet (CDS) and Patient Information Leaflet (PIL)

Check for compliance with corresponding document guidelines from the EMEA, and WHO (SmPC); specific in-depth analyses and responses to label-related questions raised by the Health Authorities

  • Clinical Expert Statements (CES)

for marketing authorization renewals according to central EMEA or national guidelines

  • Investigational Medicinal Product Dossiers (IMPDs) in Europe

for starting clinical trials in Europe according to the EU Clinical Trial Directive (2001/20/EC) effective since 2004 and the corresponding EMEA guideline

  • Investigational New Drug (IND) files in the US

for starting clinical trials in the US according to FDA

  • Investigator Brochures (IB)

in compliance with Good Clinical Practice (GCP) and ICH E6

  • Risk Management Plans (RMPs)

to apply for and maintain marketing authorization in Europe in accordance with European Commission EudraLex Vol 9A and the corresponding EMEA guideline

  • Safety Reports (e.g. Periodic Safety Update Reports, PSURs)

In compliance with ICH E2 A-F

  • Study protocols and reports

In compliance with ICH E6 and ICH E3, however, without misinterpreting these guidelines as template.

  • Bioanalytical Method Validation reports

According to the principles of Good Laboratory Practices (GLP) and guidelines from the FDA, and other national and international organizations

  • Internal strategic documents, Due Diligence dossiers, and overviews

According to the Client’s publication and strategic planning