Regulatory Affairs Consulting

At AssureImmune, we pride ourselves in being regulatory affairs experts, creating customized services based on your unique needs and internal capabilities.

Our services include assisting with Phase I, II and III clinical submission. We also work with – or function as – your head of regulatory affairs to prepare and submit Investigational New Drug (IND) applications to the FDA.

With years of IND filing experience, our services include meeting with the FDA on your behalf, acquiring the pertinent information required, including necessary preclinical data and manufacturing information – a critical step that reduces time and money.

Regulatory filings and agency interactions include the following:

Creating Meeting Requests
Authoring Briefing Documents
Meeting Preparation
Agency Meeting Participation
Meeting Follow-Up
Meeting Minutes
Agency Feedback Assessment
Follow-Up Strategies
Protocol Amendment
PI Change, Addition and Removal
Annual Report
Investigator Brochures
FDA Adverse Event Reporting
FDA Serious Adverse Event Reporting
Regulatory Project Management
Regulatory Activity SOP Development
FDA & EU Remediation (483 Observations, Warning Letters, Consent Decrees)