Ruth Rettenmeier, PhD, Senior Consultant, PAREXEL Consulting is Biologist with more than 19 year experience in in late stage product development, regulatory affairs and project management.
She is offering regulatory consulting, providing strategic support and doing project management in complex regulatory applications projects, incl. scientific and regulatory experience in preparation, compilation of documents / CTD sections and submission to authorities.
Her focus is on consulting and preparation of Module 1 and Labelling documents for all kinds of MAAs (authority approval and post approval processes) in all EU countries. She is managing complex Language Service projects (25 EU/EEA languages) within the Linguistic Review Process (EU Centralised Procedure), also consulting on Mock-up and Readability.