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