Pre-Submission & Controlled Correspondence
Pre-submission meeting strategy, briefing packages and controlled correspondence with health authorities.
Overview
Engaging agencies well before submission de-risks the entire program — an issue surfaced and resolved at scientific advice is far cheaper than the same issue raised as a major deficiency after filing. PharmExpert manages the pre-submission phase so questions are resolved early and expectations are aligned before you commit the dossier.
The value of a meeting is set by its preparation. We define the objectives and the specific questions worth asking, then author the briefing package and the anticipated-question set that frame the discussion in your favor and demonstrate a credible program.
We draft and manage controlled correspondence and meeting requests with FDA, EMA and other authorities, handling the procedural detail that keeps interactions on track, and we can rehearse your team so they present and respond with confidence.
After the meeting, we interpret the agency's responses — which are not always unambiguous — and fold them back into the regulatory and development plan. The result is a program aligned with the agency's expectations, with fewer surprises at submission.
What we do
- Pre-submission / scientific-advice meeting strategy
- Briefing-package authoring and anticipated questions
- Meeting requests and agenda management
- Controlled correspondence drafting and submission
- Agency-response interpretation and follow-up
- Meeting preparation and rehearsal support
Our process
- 1
Plan
Define meeting objectives and questions.
- 2
Prepare
Author the briefing package and correspondence.
- 3
Engage
Submit requests and manage agency interaction.
- 4
Follow up
Interpret responses and align the plan.
What you receive
- Meeting strategy and objectives
- Briefing package and anticipated-question set
- Controlled correspondence
- Meeting outcomes and action log
Who needs this
Sponsors seeking scientific advice, teams preparing pre-submission meetings, and companies needing controlled correspondence managed professionally.
Frequently asked questions
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