Agency Communications And Submissions

What We Do

We support sponsors across the full range of agency interactions, from pre-submission meetings and scientific advice requests through to CTA and IND filings and ongoing correspondence during the review process. Our team has direct experience with the MHRA, EMA and FDA, as well as a number of other national competent authorities. 

One of the things we consistently observe is that sponsors who invest properly in preparing for agency meetings, and in crafting their written communications carefully, tend to have more productive regulatory relationships. This may seem obvious, but we can help you avoid the temptation to rush these interactions despite the pressures that exist elsewhere in a development programme.

How We Work

We work with sponsors to develop a clear regulatory strategy before any agency interaction takes place. Understanding what you want to achieve from a meeting or a submission, and anticipating the questions and concerns an agency is likely to raise, makes a significant difference to the outcome. 

For formal submissions, we manage the preparation process from document collection through to final filing. For meetings and correspondence, we prepare the briefing materials and help sponsors rehearse their positions. After interactions, we help interpret agency feedback and advise on appropriate next steps.

Scope Of Service 

• Pre-submission and scientific advice meeting preparation 
• Briefing document preparation for agency meetings 
• Clinical Trial Authorisation submissions (MHRA) 
• Investigational New Drug applications (FDA)
• Meeting minutes review and response preparation 
• Responses to agency questions and deficiency letters 
• Marketing authorisation application support 
• Compassionate use and named patient programme submissions 
• Paediatric Investigation Plan negotiations 
• Orphan designation applications 
• Post-approval variation submissions 
• Liaison with regulatory agency contacts