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)
- • Guidance on borderline between medical devices and
- medicinal products (MDCG 2022)
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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