Regulatory Affairs

Regulatory strategy, submissions and communications are critical in order to achieve timely progress and maximize the value of your project. Alava offers strong experience, deep and current knowledge of regulations and expectations, and value in Regulatory Affairs support. Our features and services include:

  • Multiple VP-level consultants with FDA and international experience
  • Broad experience with product categories including gene therapy, devices, biologics and small molecules
  • Experience from preclinical stage through post-marketing
  • Organizing, writing and reviewing regulatory submissions
  • Planning and conducting regulatory meetings including pre-IND and pre-license application meetings
  • Publishing services including eCTD format
  • Requests for fast track, breakthrough therapy, priority review and orphan drug status
  • U.S. Agent representation