Regulatory Affairs

We support you with the submission of new marketing authorization applications for medicinal products with new or known active ingredients with or without innovation (generics):

• Medicinal products for human use

• Orphan Drugs

• Synthetics

• Biopharmaceuticals

• Radiopharmaceuticals

• Herbal and complementary medicinal products

• Veterinary Medicinal Products

After defining the correct approval strategy, we prepare the necessary documents:

• Dossiers in (e)CTD format, Modules 1 to 5

• Pharmaceutical Quality Dossier, Modules 3 & 2.3 incl. Active Substance Master File (ASMF)

• Non-clinical dossiers, Modules 4 & 2.4

• Clinical dossiers, Modules 5 & 2.5

• EU Drug Master Files (EDMF)

• CEP applications

We submit applications electronically using the eCTD (Electronic Common Technical Document) tool or as eDoks.

Upon request, we also provide the following services:

• Literature searches and preparation of literature-based dossiers

• Preparation of answers to official questions (e.g. LoQs)

• Preparation of meetings with authorities (scientific advice, pre-submission, clarification)

• Co-marketing applications

In the case of existing approvals, we support you throughout the entire product life cycle with necessary updates of the medicinal product dossier:

• Major changes (e.g. changes in active substance, change in dosage form or dosage strength, etc.)
• Variation requests with or without scientific evaluation, e.g. related to quality, medicinal product information or packaging material
• Submission of the PSUR/PBRER
• Renewing of a marketing authorisation
• Transfer of a marketing authorisation
• Withdrawal of a marketing authorisation

We would be happy to advise you in the following areas:

• Development of strategies for obtaining a marketing authorisation
• Assessment of dossiers (Due Diligence), e.g. in licensing projects
• Scientific consulting, e.g. for development projects
• Training of your employees, e.g. for new employees or retraining

If required, we offer the use of our Establishment license to companies without an establishment of their own in Switzerland until they have obtained their own establishment license (e.g. import and wholesale licenses including market release).

Is your product approved in the EU, and are you planning to expand into the Swiss market? We would be delighted to support you with the authorisation process:

• Adaptation of the EU dossier to the requirements of the Swiss market

If required, we offer the use of our Establishment license to companies without an establishment of their own in Switzerland until they have obtained their own establishment license (e.g. import and wholesale licenses including market release).

Further services we offer around eCTD (electronic Common Technical Document) can be found here.