Scientific and medical writing services
ranging from regulatory submissions to nonclinical and clinical documents for drug development.
Expert Regulatory and Toxicology Document Development
Product development in a highly regulated environment demands clear, concise, and convincing scientific, medical, and regulatory documents.
With our expertise in product development and regulatory affairs, we create a wide range of medical and pharmaceutical documents tailored to the needs of key stakeholders, including:
- Clinical Investigators
- IRBs (Institutional Review Boards)
- Medical Monitors
- Study Coordinators
- Regulatory Reviewers
Expert Regulatory Document Authoring & Strategic Communication
Our experienced medical and regulatory writers translate complex research data into clear, concise, and persuasive documents, ensuring regulatory compliance and success.
At Texium Solutions, our team specializes in authoring a wide range of nonclinical and clinical regulatory documents, ensuring data are well-positioned and rationales are clearly articulated to effectively communicate findings. We deliver high-quality dossiers, white papers, and brochures, including:
Investigators’ Brochures
From first-in-human to late-stage drug development brochures.
White Papers & Reviews
Literature searches and scientific reviews.
Regulatory Reports
Development of IND and NDA/BLA annual reports (e.g., DSURs).
Why Choose Texium Solutions?
Proven Expertise
Decades of experience in research informatics and regulatory compliance.
End-to-End Support
From consultation to implementation, we offer comprehensive solutions.
Scalability & Security
Future-proof solutions designed for high-performance research environments.
Seamless Integration
Compatible with leading industry platforms for a unified digital experience.
Expert Regulatory Writing
Clear, compliant, and compelling documents for seamless drug approvals.
