Regulatory Sciences
Regulatory Strategy
Chief Regulatory Officer / Head of Regulatory
Chief Regulatory Officer / Head of Regulatory
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.
Chief Regulatory Officer / Head of Regulatory
Chief Regulatory Officer / Head of Regulatory
Chief Regulatory Officer / Head of Regulatory
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.
FDA Meetings & Expedited Programs
Chief Regulatory Officer / Head of Regulatory
Submission Authoring /Medical Writing
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.
Need help with obtaining Orphan Drug, Fast Track, or Breakthrough designation?
Submission Authoring /Medical Writing
Submission Authoring /Medical Writing
Submission Authoring /Medical Writing
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.
Regulatory Intelligence
Submission Authoring /Medical Writing
Advertising and Promotional Review
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.
Advertising and Promotional Review
Submission Authoring /Medical Writing
Advertising and Promotional Review
Whether you need launch support or routine promotional regulatory affairs review, we provide regulatory support for all of your branded and unbranded activities.
Regulatory Information Management
Regulatory Information Management
Regulatory Information Management
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.