Scientific and medical writing services, ranging from regulatory submissions to nonclinical and clinical documents for drug development.
Product development in a highly regulated environment requires clear, concise, and convincing scientific, medical, and regulatory documents. Intertek’s toxicology and regulatory affairs experts have diverse scientific knowledge and extensive pharmaceutical development experience to produce custom, concise, and well-positioned documents. Based on our product development and regulatory experience, we are able to prepare a diverse range of medical and pharmaceutical documents to address the needs of various stakeholders, including clinical investigators, IRBs, medical monitors, study coordinators, and regulatory reviewers.
Intertek can assist your company with the authoring of a wide variety of nonclinical and clinical regulatory documents. Data are positioned and rationales soundly described to produce dossiers, white papers, and brochures that effectively communicate findings and results, including:
- Investigators’ Brochures, including first-in-human to late-stage drug-development brochures;
- Preparation of CMC (Quality, manufacturing), nonclinical, and clinical sections for CTD Modules 2 and 3 to support global submissions;
- Preparation of IND and NDA/BLA annual reports (DSURs, etc.);
- Literature-based regulatory submissions (including literature searches, GRADE/Rob2 assessments of published clinical studies, etc.)
- Nonclinical and clinical data summaries for multiple purposes (e.g. Regulatory documents, Board presentations, press releases, etc.)
- Orphan Drug, Fast Track, Breakthrough Therapy, and QIDP Designation Requests, and Pediatric Study Plans;
- White papers, including literature searches and reviews.
Our team of experienced writers specializes in translating complex research data into comprehensible and persuasive documents. Our commitment to quality and accuracy ensures that your documents are positioned for regulatory compliance and success.
