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

N-Nitrosamines

• • Preparation of Risk Assesments for N-Nitrosamines
• • Testing proposales for confirmatory testing