INDEVRIC Consulting

We help clients by providing strategic insight into regulatory requirements, timing and content of health authority interactions and probability of success.  Our regulatory strategy document outlines potential risks and mitigations for your development plan.  Don't have a development plan?  We can help you outline timing of clinical and nonclinical studies for each regulatory milestone.

Whether you have a one time project to answer a specific question or need ongoing support, we can search precedence and literature to help you understand the regulatory landscape and requirements for your drug development program.  Common topics include research for pediatric strategies, orphan drug designations and indication specific regulatory precedence.

Beginning with assessing whether an interaction is needed, we are there to guide your team through meetings with regulators every step of the way.  We advise on what format/type of interaction is best to insure you get the regulator input you need in the timeline you need it.  We help develop questions, sponsor positions and background briefing package and lead your team in teleconferences or face to face meetings. 

We can serve as your head of regulatory affairs or help supplement your team for specific projects or deliverables.

We can drive timelines and content for regulatory submissions such as IND/CTA and NDA/BLA.  

Maintain regulatory compliance with DSUR,  annual report, Investigator Brochure updates, CT.gov  with tracking and preparation of routine submission services.