client focusDue Diligence (DRA, NC, C, Q) and Consulting

s4s offers you expert and scientifically precise content/technology as well as strategic support in all service areas. Do not hesitate to contact us for due diligence with regard to drug regulatory affairs (DRA), nonclinics (NC), clinics (C) and analytics/quality (Q), and for expert advice in the following areas and beyond:

 

 

Medicinal Product Marketing Authorisation - Dossier Preparation
e.g. preparation of quality dossiers/expert opinions (modules 2.3, 3), non-clinical and clinical dossiers/expert opinions (modules 2.4, 2.6, 4/2.5, 2.7, 5), CTD modules 1 – 5 (human), SmPC/package insert, environmental risk assessments, Rx to OTX switch dossiers, parts 1 – 4 (veterinary); processing of deficiency notices, reformatting...

Market Introduction - Benefits Dossier (AMNOG) 
e.g. preparation of the dossier for benefit assessment in line with section 35a of the Sozialgesetzbuch V (SGB V – German Social Security Code part V) (all modules 1 – 5)...

Medicinal Product Development
e.g. preparation of scientific expert opinions, toxicological expert opinions, investigator brochures, investigational medicinal product dossiers, paediatric investigation plans/waivers/deferrals, briefing documentation for meetings with authorities, medical opinions; applications for clinical studies, evaluation of existing documentation for approval suitability/identification of gaps, medical writing for non-clinical and clinical studies...

Pharmacovigilance
e.g. preparation of periodic safety update reports, development safety update reports, EU risk management plans...

Dossier Processing and Lifecycle Management
e.g. processing of marketing approvals (planning and submittal of variations, extensions); preparation of dossiers for variations, expert opinions for extensions (quality, non-clinic, clinic) and ex ante expert opinions (AMG); transformation from NtA to CTD, and from CTD to eCTD; processing of deficiency notices (quality, non-clinic, clinic); submittal of documentation to the licensing authorities...

Scientific Expert Opinions
e.g. toxicological expert opinions, scientific expert opinions for questions related to quality, non-clinic and clinic for R&D, medicinal product development and marketing authorisation (e.g. within the scope of deficiency notices) hazardous substance classification according to the ordinance on hazardous substances...

Medical Writing
e.g. preparation of publications, study protocols and final reports of clinical and non-clinical studies...

Literature Searches and Data Analysis
e.g. for client-specific questions, within the scope of medicinal product marketing authorisations - dossier preparation, market introduction - benefits dossier (AMNOG), medicinal product development - R&D, pharmacovigilance, dossier maintenance - lifecycle management, scientific expert assessments, medical writing, project management for studies...

Implementation of Marketing Authorisation Procedures
e.g. preparation and submittal of application documentation, process handling, handling of deficiency notices...

Project Management and Quality Management of Studies
e.g. consultation, conceptualization, project management and monitoring of experiments and studies in the areas of pharmacology, toxicology, ADME and analytics...

Due Diligence (DRA, NC, C, Q) and Expert Advice
e.g. evaluation of internal and external portfolios with regard to drug regulatory affairs (DRA), nonclinics (NC), clinics (C) and quality/analytics (Q),
and expert advice in our areas of expertise...