Pauels Consulting
Scientific Consulting, Medical Writing,
Drug Regulatory Affairs

Office Steinfurt
Alleestr. 18
D-48565 Steinfurt
Phone: +49-(0)2552-9972-00
Fax:     +49-(0)2552-9971-99
http:// http:// http://
© Pauels Consulting 2008
in identifying the optimal MAA strategy (as a Europe-based consultancy, Pauels Consulting is specialized on national, decentralised, and centralised European procedures),
Pauels Consulting can assist you

in organizing advice meetings with regulatory agencies, in preparing briefing documents and presentations, as well as preparation of meeting minutes,
in coordinating MAA activities between project teams (e.g. quality, nonclinical, clinical, pharmacovigilance, RA),
in IMPD and CTD compilation (paper form as well as eCTD), and transformation of older documents into CTD format,
in life-cycle management and uptating of documentations.
Regulatory Consulting
Medical Writing
The success of a Marketing Authorisation Application (MAA) depends on the chosen application strategy, the communication with the regulators, the keeping of time lines, and the quality of the submitted documentation.