Regulatory Affairs

We are specialised on medicinal product authorisation in Switzerland. Of course, for all our services, strategic consultancy as well as taking charge of Swissmedic contacts / negotiations can be offered also.

New authorisations of medicinal products
New authorisations of medicinal products New active substances, regular and fast track procedure and procedure with prior notification.
Known active substances, without or with innovation (for example new indication, pharmaceutical form, route of administration and / or dosage recommendation).
Co-marketing of medicinal products (identical product to a already registered basic preparation).
Article 13 TPA procedure (medicinal products already authorised abroad).
For all procedures: adaptation of the EU dossier to Swiss requirements.
Life-Cycle management
Life-Cycle management Major variations (for example indication extension, new pharmaceutical form, etc.).
Variations requiring notification and variations requiring authorisation.
Update of the prescribing- and patient-information (inclusive translation proof reading, publication on Swissmedicinfo and, if applicable, Documed).
Writing and updating succinct statements.
Changes of packaging materials (inclusive maintenance of your packaging material database).
Submission of periodic reports (PSUR and PBRER, respectively and Risk Management Plans).
Modifications of authorisation status (renewal and transfer of marketing authorisations, license cancellations, withdrawal of pack sizes, etc.).
Dear Health Care Professional Letters.
Orphan Drug Status
Orphan Drug Status Application for designation of orphan drug status for medicinal products / new active substances.
eCTD For all kind of submissions (inclusive baseline submission) we can provide from compilation to validation up to publishing all electronic submission services as required.
Review of promotional material
Review of promotional material Of advertising material intended for professionals as well as for the general public, according to your internal procedures.