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 active substances, regular and fast track procedure and procedure with prior notification, temporary authorisation.
  • Known active substances, without or with innovation (for example new indication, pharmaceutical form, route of administration and / or dosage recommendation).
  • Biosimilars.
  • Co-marketing of medicinal products (identical product to an already registered basic preparation).
  • Article 13 TPA procedure (medicinal products already authorised abroad).
  • Article 14 TPA procedure (e.g., medicinal products authorised in EU/EFTA for at least 10 years).
  • For all procedures: adaptation of the EU dossier to Swiss requirements.

Life-Cycle management

  • Indication extensions, marketing authorisation extensions (for example new dosage strength, new pharmaceutical form, etc.).
  • All types of Variations.
  • Update of the prescribing- and patient-information (inclusive translation proof reading, publication on Swissmedicinfo and, if applicable, Compendium).
  • 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.).
  • Direct Health Care Professional Communications.

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

  • Of advertising material intended for professionals as well as for the general public, according to your internal procedures.


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