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The writing of registration dossiers and management of regulatory approval procedures are services that can only be provided by specialists. For “Regulatory Affairs“ we offer the following services, which can be called on a project-related basis: | | | | | | a)
| Conducting (national and EU-wide) regulatory procedures from writing of the necessary documents through to the granting of marketing authorization
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| Updating and conversion of regulatory documents to CTD format
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| Writing of Periodic Safety Update Reports (PSURs) and submission of applications for licence extensions
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| Writing, processing, submission (incl. observance of the legal regulations governing submission) and monitoring of deadlines for notices of amendments. |
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Regulatory Affairs
