Regulatory Affairs

Our international team of regulatory professionals help transition multi-national clinical trials from concept to implementation by navigating complex regulatory environments and ensuring quality and timely submissions.

Global Regulatory Strategy

Working cross-functionally with other operational departments, the Regulatory Affairs group provides important regulatory intelligence to the build out of the ideal start-up strategy for global clinical trials. Complex regulatory environments in North America, Europe and Asia-Pacific are well-understood and effectively navigated to ensure optimal regulatory and ethics approval timelines.

Regulatory Intelligence

With regulatory intelligence built on insight and experience in over 30 countries in Europe, North America and Asia-Pacific, Regulatory Affairs at Alimentiv will provide regionally and therapeutically-based considerations to support effective regulatory start-up strategies.

Partnerships

Alimentiv has secured a gnetwork of established partnerships across the world to allow for seamless regulatory support and services in a growing number of regions.

Therapeutic Expertise

Alimentiv Regulatory Affairs leverages a depth of internal therapeutic knowledge to connect drug development with clinical trial submission strategies.

Regulatory and Ethics Submissions

Putting a strategy into motion through effective planning, preparation and execution of multinational clinical trial submissions.

Comprehensive Knowledge-base

All projects are supported by Alimentiv’s large repository of country submission specifications and requirements.

Maintenance and Reporting

The principles described above are applied to all clinical trial regulatory activities, including:

  • Global Amendments
  • Notifications
  • Annual Reporting
  • End of Trial Notifications

Submission to Approval to Clinical Study Report

Regulatory Affairs at Alimentiv will manage and oversee the submission process from protocol completion through end of study reporting. This is accomplished through adequate planning and prioritizing sponsor engagement by utilizing tools to ensure transparent and frequent communication and reporting of all regulatory activities throughout the lifecycle of the project. Information flow from the sponsor and other vendors through to the local teams is closely managed to ensure timely and quality submissions.