How do we help?
We are experts on the regulatory submission process into Promotional and Medical Review. As leaders in process management solutions, we have successfully managed over 300,000 assets from initial submission to final distribution. We currently work with over 40 Pharmaceutical and Life Sciences clients, supporting a broad portfolio of brand teams, and have worked with of many of the world’s largest creative health care agencies.
Our Agency Services team successfully augments your regulatory submission department; facilitating the operational tasks and allowing you to focus on creative & strategic initiatives
Our Submission Coordinators will:
Act as subject matter experts (SMEs) on all major review platforms
Work within those systems to ensure the highest level of review readiness
Drive quality, efficiency and compliance across your agency
Prepare a clean submission including referencing, metadata and classification
Shifting regulatory guidelines, staffing limitations and multiple review iterations are challenges faced by all agencies. Whether you’re a boutique shop or a global heath care organization we can develop, or augment, your regulatory submissions department and provide proven solutions.
Our Regulatory Submissions Team will:
Assume the regulatory submission burden
Allow internal agency staff to focus on core compentencies
Develop action plans to streamline the process
Provide a scalable solution that flexes to your needs
Increase speed to market
Increase scalability, efficiency & flexibility
Improve quality and compliance
Regain focus on creative goals
Transformation through Collaboration