Regulatory Strategy & FDA/EMA Support

When this is needed

• Client-owned submissions need structured regulatory writing
• Technical and clinical content must form one coherent package
• Teams prepare for agency interactions they will lead
• EU and US expectations both matter and must stay explicit

Methodology

1. Map the ask — procedure context, audiences, evidence available
2. Structure the narrative — what belongs in which document; gaps owned by the client
3. Write & iterate — regulatory writing aligned to technical sources
4. Prepare interactions — materials for client-led meetings or correspondence
5. Hand over — client remains the party of record with agencies

Programme stages: How we work. Regional framing: EU & US support.

In scope

• Regulatory writing and documentation structuring for client-owned submissions
• Support for plans used in client-led agency interactions
• Alignment of technical and clinical content into coherent packages
• Process support consistent with applicable electronic records expectations where relevant

Example deliverables

• Submission-oriented document drafts and structures
• Strategy notes and interaction preparation materials
• Cross-functional consistency reviews

Out of scope

• Acting as FDA, EMA or a notified body
• Guaranteeing clearance, approval or CE marking
• Issuing certificates
• Receiving PHI via the public website

FAQ

Are you partners with FDA or EMA?
No — we are not partners of FDA or EMA. With the client’s authorisation, we can conduct communications with FDA or EMA on their behalf. We also support strategy, documentation and interaction preparation.

Do you guarantee approval?
No. Regulators decide. We focus on documentation quality and readiness.

Related

Device readiness · Selected work · EU & US support · Biotech & pharma