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.