Medical Writing
Would you like to have the findings of your experiments and studies carefully documented in reports or published? The precise and diligent working method of the s4s scientists guarantees optimal results, freeing you and your staff. Our scientists prepare study protocols, reports and publications based on client data and/or extensive literature searches that are precisely matched to your workflow and timetable.
The services of s4s in the area of medical writing include::
- Literature searches in all relevant databases
- Consulting in our areas of expertise
- Preparation of scientific publications
- Medical writing for non-clinical experiments (e.g. preparation of study protocols and final reports)
- Medical writing for clinical studies (e.g. preparation of study protocols and final reports)
Please also note the following s4s services:
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), 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. 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)...
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...