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
ERA helpdesk