Regulatory Affairs
The global regulatory landscape continues to produce challenges for the pharmaceutical and biotechnology industries. Evolving data, document and submission standards have created a need for new and expanded skill sets:
- Awareness and understanding of global regulatory requirements
- Experience in operational aspects such as submission publishing and compilation
- An integrated approach that combines electronic submission strategy with operational capacity to support the transition to eCTD
- An appreciation for the technology implications associated with eCTD
Octagon offers unparalleled regulatory submission expertise. Our Regulatory Affairs professionals work closely with our Regulatory Operations, Clinical Information Management and Quality Assurance personnel. Our cross-functional approach ensures that documents and data are presented in compliant format based on applicable electronic submission guidance's, regulations and specifications.
Octagon's global Regulatory Affairs team has extensive experience in providing liaison support for agency interactions and can act as U.S. Agent for global organizations seeking regulatory approval in the United States. The team also offers expert guidance and review capabilities throughout the electronic submission process.
Our Regulatory Affairs team provides electronic submission strategy that is tightly integrated with our robust Regulatory Operations, Clinical Data and technical teams. This powerful combination has positioned Octagon as the leader in electronic submission services and products.
For more information download our Regulatory Solutions Datasheet, or Contact Octagon.
