For the preparation of an application, we develop regulatory strategies for submission, type of application and selection of possible target countries, taking into account:

• Existing documentation and possible gaps
• Available literature and studies
• Review of data protection periods
• Orphan drug indications
• Possible effects on existing marketing authorisations (RUP, MRP)
• Review of the type of application

• Queries from the authorities/deficiency letters
• Strategy for presentation and argumentation in the marketing authorisation application
• Strategy for follow-up studies
• Consulting within the context of licensing projects
• Elaboration of BCS-biowaivers
• Development of strategies for scientific consultations

We are happy to take over review of your documents, reports and dossiers, in line with your current requirements and the planned intended use, as well as any applicable Guidelines and Directives. These reviews may include the following:

• Analysis of possible gaps with regard to regulatory activities, e.g. assessment of marketing authorisation dossiers within the scope of planned repeat use procedures, new submissions or in the scope of in-licensing of marketing authorisations
• Review of the consistency of marketing authorisation and manufacturing documents (regulatory compliance)
• Review of the validity of the product information texts
• Compilation of a detailed list of deficiencies, including assessment of the risks
• Preparation of an action plan for the correction and/or improvement of the dossier

We will manage planning and preparation of the pharmaceutical-technical documentation (Module 3) for the marketing authorisation documentation for new applications or as part of maintenance activities. This includes:

• Processing of raw data from the laboratory and production, generated during development
• Revision on the basis of change controls
• Incorporation of extensive re-formulations
• Verification of analytical methods and validations
• Preparation of stability reports
• Creation of ASMFs (restricted and applicant’s part)
• Elaboration of CEP documentation
• Creation of the QOS (Module 2.3)
• Risk analysis for elemental impurities

Consultations with the authorities (scientific advice) make it possible to coordinate development and regulatory strategies with the authorities. We assist you with the compilation of any preparatory documents.

• Preparation for the consultation
  • Application for the appointment and coordination with the authorities
  • Support for the creation of the questionnaire and associated documentation according to the planned development strategy
  • Accompany the consultation and taking minutes
• Follow-up of the consultation
• Development of regulatory strategies

In the context of a company acquisition or purchase of marketing authorisations or marketing authorisation dossiers and portfolios, or the evaluation of organisational structures, we support you with our extensive expertise in areas such as

• Assessment of dossiers/product portfolios with regard to the planned strategy
• Evaluation of the validity of existing marketing authorisations
• Assessment of regulatory processes
• Review of the marketing authorisation dossiers in respect of regulatory compliance
• Evaluation of development projects/product pipelines
• Evaluation of the quality management system in relation to regulatory compliance

Of course we would prepare the final report on the basis of your formal requirements.

We assume responsibility for the following notifications for you:

• xEVMPD
• Sunset clause notifications (SSC notifications)
• AMG-EV (national requirement for Germany)
• Individuals with specific responsibilities (QPPV , Graduated Plan Officer (“Stufenplanbeauftragter” for Germany), Information Officer (“Informationsbeauftragter” for Germany), QP )
• Standard marketing authorisations and registrations (for Germany)
• Application for SME status
• Setting-up and maintenance of access to authorities’ portals
• Applications for Trademarks