aca24@aca-pharma.de/

+49 341 33 73 33 60

Scientific/ regulatory advice and support

  • • Database searches/literature retrieval/data
  •    gap analyses
  • • Proof of pharmaceutical quality, pre-clinical
  •    (toxicological), clinical and regulatory aspects
  • • Advice on Marketing Authorisation strategy/
  •    Scientific Advice consultations
  • • Pre-clinical/toxicological in vitro and in vivo testing
  •    proposals and study monitoring
  • • Toxicological qualification/risk assessment on
  •    impurities, degradation products, residual solvents
  • • ADE/PDE/OEL derivation services (EMA/CHMP/ CVMP/ SWP/169430/2012)

Dossier compilation/ submission

  • • Preparation of Module 1 including Environmental Risk
  •    Assessment (ERA) and Risk Management Plans
  •    (RMP), Common Technical Document (CTD) modules
  •    2 to 5 and NtA (veterinary medicinal products)
  •    modules
  • • Regulatory/scientific supervision covering the whole
  •    application procedures (Applicant‘s Response
  •    Documents, Dossier update, Agency communication)
  • • 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)

Pharmacovigilance Systems

  • • Development and maintenance, Master File, Risk
  •    management plan Environmental risk assessment
  •    ERA testing recommendation and study monitoring

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