Regulatory Strategy & FDA/EMA Procedures

When this is needed

• Submissions need structured regulatory writing
• Technical and clinical content must form one coherent package
• Teams prepare for agency interactions they will lead — or authorise us to support
• EU and US expectations both matter and must stay explicit
• Inspection- or meeting-facing materials need disciplined narrative and traceability

How we work

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 authorised correspondence
5. Hand over — client remains the party of record with agencies unless a contract defines a specific communication mandate

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

Procedures and contexts we support

Support is scoped to the client’s pathway and the dossier that pathway requires.

• FDA-oriented programmes — documentation and interaction preparation for US pathways (drugs, biologics, devices or combination products as scoped)
• EMA / EU-oriented programmes — writing and structuring for European procedures and scientific advice pathways as agreed
• Dual-market programmes — keeping regional differences explicit while sharing scientific core where appropriate
• Device and software packages — coordination with device readiness and medical software so engineering and RA stories match

Documentation types (examples)

• Regulatory strategy notes and gap-oriented roadmaps for client decision
• Submission-oriented drafts and document structures (modules / sections as scoped)
• Clinical and technical narrative alignment across contributing functions
• Meeting packages, briefing books and Q&A preparation for client-led or authorised interactions
• Inspection-facing plan and communication support when the client authorises our participation

Electronic records and signatures expectations (including 21 CFR Part 11 themes where applicable) are handled inside the client’s controlled systems.

In scope

• Regulatory writing and documentation structuring for submissions
• Support for plans used in client-led agency interactions
• With client authorisation: communications with FDA or EMA on the client’s behalf
• 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
• Authorised agency correspondence support as defined in the SOW

FAQ

Can you speak for us in an agency meeting?
Only when the client authorises that role in writing and remains the party of record. Default mode is preparation and documentation support for client-led interactions.

Related

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

For role boundaries (regulator, notified body, certification, outcomes), see Trust.