Pharmaceuticals
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)
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
