° Strategic and operational regulatory consultancy

° Pre-submission data review and evaluation in
  the light of European requirements and national
  context/habits: chemical (DMF), pharmaceutical
  and clinical data

° Due diligence activities:

• Regulatory portfolio

• Pharmaceutical data

• Clinical data

° Organisation of meetings with Health Authorities
  and representation of the client company

° Compilation of the files in EU-CTD format:

• Preparation of Module 1

• Drafting pharmaceutical, preclinical
  and clinical overviews/summaries

• Drafting and/or layout of the whole dossier

° Follow-up: checking the progress of the application,
  preparation of replies to any questions, assistance
  with correspondence, etc.