Preparation of Dossiers

A huge amount of expense and effort is put towards product development, in terms of resource, people and money. The end aim of this is to produce a Regulatory dossier for submission to the Regulators to ensure successful authorisation and launch of your product. A proportional amount of resource should be put into the compilation and preparation of any dossier to ensure it meets the requirements in terms of content, format and quality of presentation. This is what the Regulators will read, review and use to make an assessment of your product. A well presented dossier is the first step to making a good impression.

Diamond BioPharm Limited can assist with the preparation of all types of dossiers for submission across Europe, including -

• Full Marketing Authorisation Applications
• Abridged Marketing Authorisation Applications
• Bibliographic applications
• Quality Overall Summaries
• NTA to CTD conversions
• Variations Type I and Type II
• Clinical Trial Applications
• Orphan Drug Designation applications