Global Standards
Our Expertise
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Why People Trust Us
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We Empower Science Through Precision & Partnership
At Neudrug, we combine deep scientific expertise with regulatory insight to support the healthcare, pharmaceutical, and life sciences sectors. Whether it’s high-quality medical writing, accurate multilingual translations, or reliable FSP support, our services are designed to meet international standards like ICH-GCP, FDA, and WHO guidelines. We don’t just follow best practices, we define them through collaboration, innovation, and a commitment to operational excellence.
Latest Case Studies
Rapid Investigator’s Brochure Development for Novel Biologics
Client: Confidential Biotech Company
Therapeutic Areas: Autoimmune and Dermatology
Services: Medical Writing – Investigator’s Brochure (IB)
Project Summary
NEUDRUG provided rapid development of regulatory-compliant Investigator’s Brochures to support early-phase clinical trials for multiple novel biologic assets targeting autoimmune and dermatological diseases.
Assets Overview
Asset A: Biologic targeting IL-15 receptor, designed to modulate autoreactive immune cells in an autoimmune skin condition.
Asset B: Antibody against IL-15, addressing immune dysregulation in a chronic autoimmune gastrointestinal disorder.
Asset C: IL-4 receptor antagonist developed for inflammatory skin disease management.
Execution & Results
Delivered high-quality IBs within 5 days each, aligned with FDA and ICH guidelines.
Ensured scientific accuracy through detailed data review and sponsor collaboration.
IBs approved by FDA without major comments, enabling on-schedule trial initiation.
Client engaged NEUDRUG for additional regulatory writing and translation services.
Client Feedback
“NEUDRUG’s expertise and fast turnaround were critical in meeting our regulatory deadlines and launching our trials successfully.”
“Excellent consultation — NEUDRUG’s team, demonstrated deep expertise, provided precise guidance, and addressed all our questions thoroughly.”
Biotech
(Poland)
“NEUDRUG expertly crafted our protocol and efficiently guided us through the IRB approval. Their support was invaluable and timely.”
Derma Clinic
(Texas and California, USA)
“Thanks to NEUDRUG’s thorough and compliant documentation, we secured IRB approval for our oncology study and on schedule. Their professionalism made the difference.”
Biotech
(Michigan, United States)
