+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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