Your regulatory pathway shouldn’t be a black box. We believe in collaboration, transparency, and a strategy tailored to your specific goals.

Traditional regulatory consulting can feel like handing off your project into a void. At CoreQ, we do the opposite. We integrate with your team, leveraging a structured yet agile methodology to ensure you are informed, empowered, and in control every step of the way.

Our approach is built on three core pillars:

Pillar 1: Deep Discovery & Strategic Roadmapping

We begin by listening. Before we prescribe a solution, we dedicate time to fully understand your technology, your business objectives, and your timeline.

• Phase 1: Immersion Workshop: We conduct an in-depth kickoff meeting to understand your product’s science, your target market, and your company’s unique strengths and challenges.

• Phase 2: Gap Analysis & Pathway Assessment: We perform a thorough analysis of your existing data and documentation against regulatory requirements, identifying potential hurdles and opportunities early.

• Phase 3: Strategic Roadmap Development: We deliver a clear, actionable regulatory strategy document. This is your roadmap, outlining key milestones, timelines, and investment requirements—with no surprises.

Pillar 2: Agile Execution with Total Transparency

Execution is where many firms fail. We combine deep expertise with a modern, agile project management approach to keep your project on track and on budget.

• Integrated Team Sprints: We work in defined sprints with clear deliverables, allowing for flexibility and rapid iteration based on feedback or new data.

• Your Dedicated Dashboard: Gain 24/7 access to our client portal for real-time updates on project status, document versions, and milestone tracking. No more guessing.

• Fixed-Fee Projects: We believe in predictable pricing. Most of our projects are scoped with fixed fees, so you can manage your budget effectively.

Pillar 3: Continuous Partnership & Advocacy

Our relationship doesn’t end at submission. We partner with you for the long term, ensuring ongoing compliance and supporting your product’s lifecycle.

• FDA Meeting Partnership: We prepare meticulously and stand by your side (virtually or in-person) for all critical FDA interactions, ensuring your voice is heard clearly and confidently.

• Post-Market Stewardship: We help you establish robust post-market surveillance systems, manage reporting, and plan for future changes or expansions.

• Strategic Business Advisory: As trusted partners, we provide insights on how regulatory strategy impacts business development, fundraising, and M&A activities.