Sirius Regulatory Consulting offers significant experience and expertise in managing submissions from IMPDs and clinical trial authorisations to applications for Marketing Authorisation.

We assist clients in all aspects of submission management, including:

• Pre-submission dialogue and meetings with national authorities, Reference Member State, Rapporteur, and EMEA, as
  appropriate
• Submission of dossier through to successful validation
• Preparation, review and optimisation of responses to deficiency questions
• Management of clarification meetings with the regulatory authorities in order to optimise format and content of response
  documents
• Support at formal hearings, including oral explanations with CHMP


eCTD is increasingly becoming the format of choice for applications for Marketing Authorisation. Sirius Regulatory Consulting assists clients in all aspects of the preparation and optimisation of eCTD's. As required, we provide our clients with full eCTD compilation and submission capability through our strategic partnership with Datafarm Inc. Together, Sirius Regulatory Consulting and Datafarm provide a unique combination of Regulatory Consultancy and eCTD submission capability as one integrated service.

Whether the route of choice for EU Marketing Authorisation is Centralised, Decentralised or Mutual Recognition, Sirius Regulatory Consulting is positioned to support you in achieving success.