Regulatory Affairs

MARAS AG
Gewerbestrasse 5
CH-6330 Cham
Switzerland

Tel. +41 41 747 3131
Fax +41 41 747 3130

mail@maras.ch

Regulatory Affairs Services

We offer the complete range of services for registration purposes, including evaluation of your dossier, submitting your Marketing Authorization Application (MAA) and accompanying your product during its whole life cycle.

In-depth evaluation of your dossier and offering of solutions to compensate for eventual deficiencies
Definition of Regulatory Affairs strategies
Bibliographical research
Preparation and follow-up of Marketing Authorization Applications (MAA) in CTD-format, adaption to Swissmedic standards
Preparation of European core dossier
Writing of Overviews / Expert Reports and Summaries
Reformatting of documentations from NTA format into CTD format
Renewal of registrations and applications for variations
Filing of applications for reimbursement with the Federal Office of Public Health
Development of GSASA data sheets
Coordination of Pharmacovigilance responsibilities
Submission of Periodic Safety Update Reports
Reviewing of advertising concepts and materials