reliabilityImplementation of Marketing Authorisation Procedures

The technical and content development of complex authorisation documentation is followed by submitting the authorisation documentation to international or national authorities. These authorities decide whether the medicinal product is approved, which is a prerequisite for its marketing.

s4s ensures that your authorisation documentation is in line with current requirements and completed on time. s4s handles your national and international projects from the planning to the approval stage, including the preparation of application documents, submittal of applications to authorities, handling of all processes and processing of deficiency notices. Throughout all phases of the marketing authorisation process, we are the competent contact for our clients and the licensing authorities.

 

The services of s4s for the handling of marketing approval processes include:

  • Preparation of the authorisation documentation in accordance to current requirements
  • Handling your national and international projects from the planning to the approval stage, including the preparation of application documents, submittal of applications to authorities, handling of all processes and processing of deficiency notices.
  • Competent contact for the clients and the licensing authorities throughout all phases of the marketing authorisation process

 

Please also note the following s4s services:

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...

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...