aca24@aca-pharma.de/

+49 341 33 73 33 60

Scientific / regulatory advice

  • • Proof of completeness of pharmaceutical, pre-clinical
  •    (toxicological) and clinical data
  • • Closure of data gaps, literature searches
  • • Advice on Marketing Authorisation strategy
  • • Scientific Advice consultations
  • • Pre-clinical/toxicological in vitro and in vivo testing
  •    proposals and study monitoring
  • • Toxicological qualification of impurities, residual
  •    solvents
  • • PDE/OEL derivation
  •    (EMA/CHMP/ CVMP/ SWP/169430/2012)

Dossier compilation / submission

  • • Preparation of CTD Modules 1 to 5
  • • Regulatory/scientific supervision concerning
  •    Applicant‘s Response documents, agency
  •    communication, dossier update
  • • Dossier maintenance services, variations

Medical writing and Pharmacovigilance services

  • • Dossier preparation according to NTA
  • • Clinical Trial Application (CTA)
  • • Preparation of Investigational Medicinal Product
  •    Dossiers (IMPDs), Investigator‘s Brochures (IBs),
  •    Investigational Clinical Trial Reports (ICTRs)
  • • Biometrics/pharmacokinetic data analysis
  • • Supervision/adaptation of Summary of Product
  •    Characteristics (SPCs) and Package Information
  •    Leaflets (PILs)
  • • Publication of experimental/clinical data in
  •    peer-reviewed journals
  • • Preparation of RMP, Periodic Safety Update Reports
  •    (PSURs), Individual Case Safety Reports (ICSRs)

Environmental Risk Assessment (ERA)

  • • Testing proposals and study monitoring
  • • Preparation of ERA reports

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