Keep Your Promise

We specialise in project management of clinical submission files including NDA, MAA or pediatric development/study plans and provide document leadership and expert medical writing expertise. We organise the objection – response process prior to final approval and help articulating clear and concise replies to authority concerns.

We manage, organise, and prepare clinical study protocols and reports, IND, briefing books, IBs, PIP/PSP, summary documents, clinical overvies and much more, and ensure that everything is according to standards and expectations.

We help you keep your promise to investigators and patients

Contact name:

Ulla Jessen


Ole Maaløesvej 3, 2200 Copenhagen N





Number of employees:


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