1.0 Qualifications
Credentials & Publications
Every certification examined. Every journal peer-reviewed. Every submission regulation-tested.
"The Clinical Study Report is one of the most critical documents in a marketing authorization application. By reading it, one can understand why and how the study was conducted — and the nature of conclusions that may be drawn."
ICH E3 Guideline · Structure and Content of Clinical Study Reports
The Orphan Drug That Almost Missed Its Window
The Problem
A gene therapy biotech had Phase III data in hand — 847 patients, primary endpoint met — and no medical writer sixty days before their NDA submission deadline. Their previous writer had exited mid-project. The FDA clock was running.
The Method
Structured authoring protocols established in 72 hours. ICH E3-compliant CSR drafted in parallel with ongoing statistical review. All 14 appendices authored simultaneously. Regulatory narrative aligned with the Priority Review justification letter.
The Outcome
NDA accepted for filing. Priority Review designation granted. FDA action letter issued within 6 months. The therapy is now approved and treating patients with the rare neuromuscular condition.
60
Days to submission
Priority
Review granted
1st
Round acceptance
18days
Average turnaround from data lock to submission-ready draft
Across 142 regulatory submissions, 2019–2026
The Cardiovascular Trial That Needed Two Audiences at Once
The Problem
A mid-size pharma brand manager needed the same Phase II cardiovascular data written for three outputs simultaneously: a JAMA submission, a 200-page CSR for the FDA module, and a plain-language summary for the trial registry — all before a PDUFA date that left no margin.
The Method
Parallel authoring streams with shared evidence base. Manuscript drafted to JAMA's Instructions for Authors. CSR structured to ICH E3 with statistical review integration. Plain-language summary written to FDA guidance on lay summaries, reviewed for sixth-grade readability.
The Outcome
JAMA manuscript accepted after single round of minor revisions. CSR filed on schedule. Plain-language summary cleared FDA review without additional queries. Brand manager reported zero back-and-forth with the agency on document quality.
3
Documents, 1 deadline
JAMA
Accepted, 1 revision
0
FDA document queries
91%
Repeat client rate across biotech and pharma engagements
Because the second submission is always more complex than the first
The CRO With Twelve Submissions and Eleven Writers
The Problem
A contract research organization managing twelve concurrent IND submissions had one writer leave unexpectedly, leaving an oncology module — the most complex in the portfolio — without an author with four weeks to the FDA deadline.
The Method
Rapid protocol review and gap analysis in 48 hours. IND Module 2 (Overview) and Module 5 (Clinical Study Reports) authored to FDA guidance. Cross-referenced with the sponsor's existing preclinical data package. Integrated seamlessly into the CRO's document management system.
The Outcome
IND submitted on schedule. FDA issued Study May Proceed with no clinical holds. CRO retained Prescribe as preferred medical writing partner for all oncology submissions. Three additional engagements followed within six months.
4
Weeks, zero clinical holds
48h
Gap-to-authoring start
+3
Follow-on engagements
2.0 Scope of Services
Every document the FDA expects to see.
From first IND through post-approval labeling. One writer who knows the full arc.
NDA & BLA Submissions
Full Module 2 and Module 5 authoring to CTD structure. ICH E3-compliant CSRs. Statistical analysis plan integration. FDA reviewer-ready on day one.
IND Applications
Phase I through Phase III IND modules. Investigator Brochures. Protocol synopses aligned with FDA guidance.
Clinical Study Reports
ICH E3-structured CSRs from data lock to final draft. Parallel review with biostatistics. All 14 appendices authored. Average 18 days from data lock.
Journal Manuscripts
Submissions to The Lancet, JAMA, NEJM, Nature Medicine, and disease-specific journals. ICMJE guidelines. Author disclosure management.
Plain-Language Summaries
FDA-required lay summaries. EMA results disclosure. Written to sixth-grade readability. Trial registry submissions. Patient advocacy versions.
4.0 Engagement
Your PDUFA date doesn't move.
Every engagement begins with a 30-minute scoping call. Tell me the therapeutic area, the document type, and the deadline. I'll tell you exactly what's possible.
Discuss Your Submission
Response within one business day
Free Resource
The Biotech Leader's Checklist for First-Time NDA Submissions
32-point checklist covering CTD structure, statistical requirements, labeling coordination, and the five formatting errors that trigger FDA information requests.
What clients say
"The CSR came back from FDA with zero formatting queries. First time that's happened in twelve years of submissions."
Dr. Priya Nambiar
VP Clinical Operations, Vexara Biologics
"We had sixty days and a gene therapy NDA. She delivered every module, on time, FDA-ready. Priority Review granted."
Marcus Hoffmann
CEO, Cellpath Therapeutics