Scientific and medical writing services, ranging from nonclinical, peer-reviewed manuscripts to regulatory submissions and clinical documents
Intertek’s medical and pharmaceutical experts have diverse scientific knowledge and extensive experience of pharmaceutical development to produce clear and concisely worded documents for medical and pharmaceutical companies worldwide. Based on our industry experience and regulatory interactions, we are able to prepare a diverse range of medical and pharmaceutical documentation to address the needs of various stakeholders, including clinical investigators, IRBs, medical monitors, study coordinators and regulatory reviewers.
Intertek can assist your company with all nonclinical and clinical Associated Regulatory Tasks including:
- Investigators’ brochures, including first-in-human to late-stage drug-development brochures
- Product Monographs, Package Inserts, etc.
- Phase 1 through Phase 4 clinical study protocols and amendments
- Write or review clinical study reports (Phase 1 through Phase 4)
- Position nonclinical safety data and findings to clinicians
- Nonclinical or Clinical interim data summaries
- Preparation of nonclinical and clinical sections for CTD Module 2
- Preparation of IND annual reports
- Data and safety monitoring board reports
- Prepare SAE reports for submission to all required authorities, IRBs, Agencies
- Positioning of scientific information for Orphan and Fast Track Applications
- Write and maintain Targeted Product Plan (TPP)
