Our Services

Our core expertise is providing regulatory insights and efforts throughout product development and US marketing. We work with companies of all sizes, and across most therapeutic areas. We have particular expertise with Class II and III implantable medical devices, and software driven electromechanical devices.

We pair our deep knowledge of FDA regulations and current regulatory environment with a practical understanding of the medical device industry.

Regulatory Strategy

Developing strategies that integrate business objectives with regulatory requirements

  • Evaluating least burdensome regulatory pathways 

  • Assessing product development plans (pre-clinical, clinical)

  • Creating regulatory roadmaps that integrate product indications, specific technological characteristics, and market needs

  • Developing testing strategies that align with regulatory expectations

  • Identifying potential regulatory risks and mitigation strategies

FDA Interactions

Helping companies engage effectively with FDA before, during, and after major milestones, and building productive relationships

  • Supporting FDA meetings

  • Preparing for advisory Panel meetings

  • Facilitating interactive communications to resolve fast turnaround questions

FDA Submissions

Outlining, writing, reviewing, and submitting of a range of FDA submission types

  • Investigational Device Exemptions (IDE)

  • Premarket Notification (510(k))

  • De Novo Applications

  • Premarket Approvals (PMA)

  • Q-Submissions (Pre-Submissions, Submission Issue Requests, etc.)

  • Breakthrough Device Designation Requests

  • Safer Technologies Program (STeP) Applications

  • Request for Designations (RFDs) and Pre-RFDs for combination products

  • 513(g) Request for Information

Regulatory Remediation

Things happen — we can help

  • Resolving FDA deficiencies: triaging questions, establishing working groups, updating timelines, overall response strategy

  • Authoring responses to FDA questions or strategies for re-submission

  • Writing appeals, working with FDA’s ombudsman

  • Legacy product management:

    • Reviewing previous letter-to-file changes

    • Determining need to submit “Catch-up” 510(k)s