01Regulatory strategy & global submissions
Strengthen the regulatory position before submission, renewal, or Notified Body review.
A pathway or submission question rarely stays isolated. It can affect evidence, claims, risk management, quality controls, post-market obligations, technical documentation, and the response the organisation must defend.
SHOTUNE provides founder-led regulatory advisory for Class I–III medical device companies navigating FDA, EU MDR, global pathways, renewal, remediation, and Notified Body review. The work examines the available documents, tests the regulatory logic, identifies material gaps, and clarifies a more defensible path forward.
A private first conversation to understand the decision, locate the exposure, and determine whether SHOTUNE is the right fit.
Defined engagements
Where this becomes a defined engagement
When the regulatory question has moved from broad pathway or submission strategy into a bounded review with named outputs, these are the two defined starting points.
The decision context
Leadership needs to understand what the regulatory decision changes across the submission position.
Pathway, classification, claims, renewal, and regulator-response decisions can change evidence requirements, technical documentation, risk conclusions, post-market obligations, approval timing, and product sequencing. Those dependencies need to be visible before separate teams act on different assumptions.
Approval timelines
Identify the assumptions, dependencies, and gaps most likely to create delay, rework, or repeated regulatory review.
Market access strategy
Keep the pathway, intended use, claims, and evidence position aligned with the markets the business intends to enter.
Submission and review confidence
Make the regulatory rationale, unresolved gaps, supporting evidence, and decision dependencies easier for leadership, technical teams, and external reviewers to examine.
Cross-functional execution
Give regulatory, clinical, quality, product, and cross-functional teams one clearer position to carry into the next phase of work.
When to escalate
Escalate when the technical question begins weakening the submission position.
Senior regulatory judgment becomes especially important when the issue crosses functions, the response posture is no longer clear, or delay is beginning to reduce the organization’s available options.
- Pathway, classification, claims, or submission logic no longer align.
- FDA or Notified Body feedback is exposing deeper evidence, quality, or strategy gaps.
- Internal teams are working from different assumptions about the same regulatory issue.
- A major submission, remediation effort, product change, or market expansion requires an executive decision.
- Regulatory uncertainty is beginning to affect timing, technical-documentation readiness, product continuity, or review confidence.
Strategic scope
Where SHOTUNE brings the regulatory decision back into view.
The work focuses on the pathway, regulatory position, supporting documents, regulator-facing logic, and cross-functional dependencies that require senior attention before additional work proceeds.
Pathway strategy
Evaluate FDA, EU MDR, and global pathway options against the device, evidence, intended use, claims, timing, technical-documentation status, and regulatory context.
Classification and positioning
Clarify classification, predicate, intended use, pathway, and claims assumptions so the regulatory position can be understood and defended.
Response and change governance
Strengthen the response posture, escalation logic, and decision ownership when regulator feedback, product changes, or internal misalignment are increasing exposure.
Submission and Notified Body readiness
Prepare the regulatory narrative, supporting rationale, decision history, technical documentation, and unresolved questions for submission, Notified Body review, or executive scrutiny.
The connected submission position
Regulatory strategy works only when evidence, claims, quality, and execution support the same position.
A pathway decision can change the evidence plan, claims posture, risk conclusions, quality controls, post-market obligations, technical documentation, and review timing. SHOTUNE helps leadership identify where those positions no longer agree before each function solves a different version of the problem.
Evidence
What the intended pathway, indication, and claims require the clinical evidence plan to support.
Claims
What the organisation can state consistently across submissions, labelling, clinical materials, external claims, and the technical file.
Quality
How the regulatory position must be carried through design change, risk management, documentation, and quality controls.
Leadership
Which assumptions, tradeoffs, timing decisions, and response choices require visible executive ownership.
Portfolio continuity
How one regulatory decision may affect renewal timing, product sequencing, market access, document dependencies, and continued product compliance.
Founder accountability
Senior judgment remains close to the work from the first assessment through the next decision.
Every regulatory engagement is led directly by Dr. Shola Sulaimon. She works with leadership and technical teams to evaluate the available evidence, challenge assumptions, connect the regulatory issue to its wider consequences, and clarify what the organization must decide next.
The objective is not certainty where none exists. It is a stronger and more defensible position that leadership understands, technical teams can execute, and the organisation can carry into submission, regulator interaction, renewal, remediation, or Notified Body review.
Frequently asked questions
Questions leadership often brings into the first conversation.
We have a stalled FDA or CE Mark submission. Can SHOTUNE step in midstream?
Yes. SHOTUNE can review what has already been submitted, the feedback received, the assumptions behind the current strategy, and where the pathway, evidence, claims, or response logic may no longer align.
The first task is to determine what remains usable, what is creating continued exposure, and which decision must be made before more work proceeds.
Our pathway, classification, or predicate is still unclear. Can SHOTUNE help us decide?
Yes. SHOTUNE helps leadership compare the regulatory options, supporting assumptions, evidence implications, timing, and downstream consequences so the organization can understand what each path requires and what may be placed at risk.
FDA or Notified Body feedback keeps escalating. How does SHOTUNE help?
Repeated or expanding feedback can indicate a deeper gap in the regulatory position rather than a series of isolated document problems.
SHOTUNE examines the pathway, evidence, claims, risk, quality alignment, and response logic together, then helps leadership identify which issue must be resolved first.
Does SHOTUNE engage directly with FDA and Notified Bodies?
SHOTUNE can support pre-submission planning, formal interactions, written responses, meeting preparation, and escalation strategy. The appropriate scope depends on the product, regulatory stage, existing team, and decision requiring support.
How is SHOTUNE different from a traditional regulatory consulting firm?
SHOTUNE is founder-led, cross-functional, and decision-focused. The work is designed for situations where leadership needs senior judgment close to the regulatory issue and the clinical, quality, risk, post-market, technical-documentation, and execution dependencies connected to it.
The objective is not to produce additional document volume without first clarifying the position those documents are meant to support.
What outcome should leadership expect from an initial engagement?
The organization should leave with a clearer understanding of the regulatory decision, the assumptions supporting the current position, the connected exposure, the available options, and the next decisions or workstreams that require ownership.
Can SHOTUNE help when prior advice has already caused rework or lost momentum?
Yes. SHOTUNE can assess the existing work, identify where assumptions, evidence, or cross-functional alignment broke down, and help leadership determine what should be retained, corrected, or reconsidered before additional work proceeds.
The next step
Need regulatory clarity before the next decision becomes harder to reverse?
Bring the pathway, submission, regulator response, product change, or governance issue. The first conversation is used to understand the context, locate the connected exposure, and determine whether SHOTUNE is the right fit.
One focused conversation to clarify the decision, the exposure, and the next responsible step.