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.
Regulations are continuously in flux. Our experienced team members can summarize new regulations/ changes to regulations AND provide an impact assessment, create a "company position" statement and develop an implementation plan to suit your company's needs and tie into your change management program.
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.
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.
Whether you need launch support or routine promotional regulatory affairs review, we provide regulatory support for all of your branded and unbranded activities.
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 and provide leadership support to regulatory operations and project management teams.
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.
Effective RIM systems and processes are essential to high performing regulatory teams, Our consultants can assess your RIM environment, recommend options and assist with the deployment of process and technology solutions.