Professional Regulatory Affairs Services

A-consult offers professional regulatory affairs assistance in all areas, some of them being:

• Total outsourcing of RA
• Outsourcing of specific tasks exceeding your present RA capacity
• Continuous support to optimize your RA capacity
• Writing, evaluating and compilation of Marketing Authorization Application dossiers, incl. summaries, overviews, SPC and PL
• Preparation and submission of clinical trial applications
• Updating dossiers and converting dossiers to CTD format
• Preparation of eCTD and NeeS dossiers
• Worldwide submission of MAA dossiers and variations