Full-service regulatory affairs, from strategy to submission.

Regulatory approval moves your product from innovation to market. Defining a regulatory strategy that maps your journey through the approval process is critical but understanding the regulatory requirements that govern your market takes a broad knowledge base and a wide range of expertise.

Alira Health is a full-service regulatory partner with decades of global regulatory experience and a cross-functional team to ensure tailored strategies, efficient submissions, and successful approvals.

Click the links below to explore our services.

The Alira Health Regulatory Affairs practice is led by Mary McNamara-Cullinane, RAC. Mary brings over 25 years of regulatory experience to Alira Health. She previously led her own consulting firm (MMC Regulatory Consulting). For more information, please contact Mary.

Strategy and Roadmap Development

The first step in a successful regulatory submission is a sound strategy and executable roadmap to gain the approvals needed to bring your product to market. Alira Health’s team of regulatory experts, doctors, scientists, and strategists take a holistic view in creating your regulatory strategy and plan, ensuring that regulatory requirements and your business objectives are met. Our strategies are focused on helping you balance risk, increase speed, and decrease costs associated with:

  • Streamlining regulatory strategy in line with client marketing claims, indications for use and business objectives
  • Orphan Designations
  • Breakthrough Designations
  • Fast Track Designations
  • Adaptive Design Programs
  • Direct-to-patient Programs
  • Hybrid Programs
  • PRIME Programs

Submission Management

We work with you to prepare, review, and file submission documents to address regulatory concerns and minimize inquiries associated with:

Medical Devices

  • Pre-Submission Preparation and Submissions
  • Lead and Manage FDA Meetings
  • 510(K) Premarket Notifications
  • DeNovo 510(k) Premarket Notifications
  • Investigational Device Exemption Applications (IDES)
  • PMA’s -Premarket Approval Applications
  • 513(G) Requests for Classification
  • Requests for Designation
  • Technical Files / Design Dossiers for CE Mark
  • Premarket Approval Applications (PMA’s)
  • Canadian License Applications

Biologics/Pharmaceuticals

  • Pre-IND Meeting preparation and submissions
  • Lead and Manage Pre-IND Meeting
  • BLA/NDA Submissions
  • INDS/CTAS/ and Post Filing Submissions

FDA US Agent for Non-US Companies

As a global company, headquartered in the US, we understand the challenges associated with FDA regulatory for non-US companies. Our team of US-based project managers have years of experience working with the FDA and regularly guide our clients through the process of FDA liaison.

Alira Health experts serve as a liaison for clients in active negotiation with regulatory bodies, providing expertise and guidance on:

  • FDA Establishment Registration
  • FDA US Agent for Foreign Establishments
  • EU Authorized Representative

For more information, please contact Mary.