Medical, Regulatory, Scientific Affairs

Agility Clinical was founded to provide companies with a full complement of services needed for successfully develop orphan drugs and new treatments for rare diseases. Our team understands how to overcome the challenges associated with finding and developing new treatments for orphan indications and rare diseases. Whether your product is classified as a drug, a device or a combination drug-device, Agility has the expertise to help develop and execute your plan for all phases of development through marketing approval.

Agility’s Medical, Regulatory & Scientific Affairs team is comprised of medical, regulatory, and scientific experts who will help you deliver on aggressive timelines while ensuring patient safety and regulatory compliance.

We offer the following services to supplement your in-house expertise and welcome the opportunity to help you with other unique project or staffing needs.

Medical Affairs

  • Medical Monitoring
    • Physicians provide medical monitoring, available 24/7, if requested
  • Safety Surveillance
    • Intake, triage, case processing and reporting of Serious Adverse Events by experienced health care professionals
  • Medical Coding
    • MedDRA and WHODrug Coding
  •  Pharmacovigilance
    • Safety data review and safety summaries for data monitoring committees, safety review committees, adjudication committees
    • Signal detection

Regulatory Affairs

  • Prepare, review, and/or submit regulatory applications and reports. Examples include:
    • Orphan Drug Applications
    • Fast Track Designation Requests
    • Pediatric Study Plans and Waiver Requests
    • INDs
    • IND Annual Reports, DSURs, PSURs, PADERs
  • Other regulatory submissions, including;
    • INDs, protocol amendments, IND annual reports, DSURs, PSURs, PADERs, expedited serious adverse events
  • FDA Meetings
    • Prepare, review, and/or submit meeting requests
    • Prepare, review and/or submit Background/Information Packages
    • Preparation, attendance and management of FDA Meetings
  • Electronic submission of submission-ready reports and regulatory documents provided by the sponsor and/or prepared by Agility Medical Writers according to FDA Guidelines.
  • Consulting, strategy development, representation with US and ex-US regulatory authorities
  • Serve as US Agent for foreign companies
  • Post market promotional review

Scientific Affairs

  • Literature and/or data reviews on a variety of scientific topics
  • Due diligence
  • Gap analysis for legacy projects
  • Consultants in specific disciplines or therapeutic areas