ConForte ApS provides regulatory assistance
- in your offices as a professional part of your team
- or we can assist you with single tasks like submitting a variation application.
- or you could request a project like compiling, submitting and follow-up on specified applications.
ConForte's expertise in RA is:
- Quality review and evaluation of dossier's, modules, reports, Drug Master Files and other relevant documentation for submission.
- Expert reports, Summaries and Overviews.
- SPC and labelling information updates.
- Readability user testing of PIL's
- Write and compile abridged and bibliographic applications.
- Regulatory submission strategies.
- Professional contact with relevant agencies and follow-up during the registration procedures.
- Processing line extensions.
- Processing variation applications.
- Processing renewals
- Compile and monitor variation packages world wide.
- Professional scientific advice.
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