We can develop a high-level regulatory strategy, a detailed regulatory roadmap or assess your existing roadmap for potential gaps and provide recommendations on how to address those gaps.
Effective regulatory project management is critical for an on-time, on budget submission. We can help you manage your milestones, task, and issues while mitigating risks.
Need an extra pair of hands to author submission components? Or someone to critically review documents? Perhaps a medical writer to QC the documents provided by your CMO, CRO, etc.?
We can help.
Are you prepared for when the Health Authority calls? We can act as your primary point of contact for agency inquiries, negotiate your label and defend your submission. Additionally, we can provide back of the house support for effective responses to Health Authority questions.
Meetings with the agency can be daunting. From developing briefing package to preparing you for the big day, we focus on the details so you can focus on the meeting.
Whether you need launch support or routine promotional regulatory affairs review, we provide regulatory support for all of your branded and unbranded activities.