Selected Regulatory Writing Case Studies

Dunwoody Consulting has provided strategic regulatory and medical writing support to biotechnology and global biopharmaceutical companies across all stages of clinical development. The following case studies highlight selected engagements and capabilities.

Clinical & Commercial Literature

We bridge the gap between complex clinical data and crisp, impactful design. Our medical communications brochures are meticulously crafted to deliver accurate science while maintaining high visual engagement, ensuring your therapeutic messaging resonates clearly with healthcare professionals and stakeholders alike.

Brochures

AltaPore Bioactive Bone Graft

Baxter Dura-Guard Dural Repair Patch

Baxter Floseal Hemostatic Matrix

Baxter Peri-Strips Dry with Secure Grip

KabaFusion Immunoglobulin Therapy

Kingle Medical Management Flyer

Kingle Medical Management Trifold

Neulark Parkinson’s Disease Clinical Trial

Stephen J. Mathes, MD

Websites

Adhesions.me

kabafusion.com

Neulark.com

Scientific Communications

Developing publication-ready content that reflects scientific rigor, clarity, and strategic narrative development.

Abstracts and Posters

Rationale and Design of a Prospective, Randomized, Double-Blind, Dose-Comparison Safety and Tolerability Study of GRF6019 in Mild to Moderate Alzheimer’s Disease

Real-World Utilization of Human Fibrinogen Concentrate in Managing Bleeding in Adult and Pediatric Patients: A Retrospective Study

Efficacy and Safety of PlasmaCap IG, a New 10% Intravenous Immunoglobulin Manufactured Using an Innovative Chromatography Process, In Adults and Children with Primary Immunodeficiency Disorders

Evaluating the Efficacy and Safety of an Intravenous Human Plasma-Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants with Congenital C1-Inhdeficiency for the Treatment and Pre-Procedure Prevention of Acute Hereditary Angioedema Attacks

Phase 2 Trial Results of Topically Administered ILYX-002, a Novel Immune Modulator for Inflammatory and Autoimmune Dry Eye Disease

Implementation of an IGIV-sparing Treatment Protocol for Immune Thrombocytopenic Purpura (ITP) in a Large Children’s Hospital

Full Publications

The role of BAFF and APRIL in IgA nephropathy: pathogenic mechanisms and targeted therapies

Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens

Postoperative Pelvic Abscess Risk in Gynecologic Surgery: A Four-Year Single Institution Experience

Overview of subcutaneous immunoglobulin 16.5% in primary and secondary immunodeficiency diseases

Customizing subcutaneous immunoglobulin administration in primary antibody deficiency: patient-centric care perspectives

A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy

The changing patient profile: A retrospective study of trends in perioperative bleeding management and challenges in surgical care

Dunwoody Consulting

As an integrated, professional communications firm, we leverage solid rsearch, science and expertise to develop collaborative, innovative solutions for our clients.