Welcome to s4s Tries service!
s4s is your reliable partner for services in the healthcare sector. We offer you expert consultation and reliably support you in all professional tasks.
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our range of services with you!
s4s Tries service GmbH & Co. KG
Phone: +49 7391 7558881
Fax: +49 7391 7558882
More than 10 years s4s
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s4s offers you the following:
Medicinal Products 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), traditional use dossies, 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 authorisation suitability/identification of gaps, medical writing for non-clinical and clinical studies...
e.g. preparation of periodic safety update reports, periodic benefit risk evaluation reports, development safety update reports, EU risk management plans, pharmacovigilance system master files...
Dossier Processing and Lifecycle Management
e.g. processing of marketing approvals (planning and submittal of variations, renewals); preparation of dossiers for variations, expert opinions for renewals (quality, non-clinical and clinical expert statements; addendum to the quality, non-clinical and clinical overview) 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 use in 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...
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 update - lifecycle management, scientific expert opinions, medical writing, project management for studies...
Implementation of Marketing Authorisation Procedures
e.g. preparation and submittal of the application documentation, process handling, handling of deficiency notices...
Project Management and Quality Management of Studies
e.g. consultation, conceptualisation, project management and monitoring of experiments and studies in the areas of pharmacology, toxicology, ADME and analytics...
Due Diligence (DRA, NC, C, Q) and Consulting
e.g. evaluation of internal and external portfolios with regard to drug regulatory affairs (DRA), nonclinics (NC), clinics (C) and analytics/quality (Q),
and expert advice in our areas of expertise...