Expert Medical Writing in Clinical Research
Our Medical Writing Services provide high-quality, scientifically accurate documentation for clinical trials, regulatory submissions, and scientific publications.
We specialize in delivering clear, concise, and compliant documents tailored to meet the needs of pharmaceutical, biotechnology, and medical device companies. Our expertise ensures your documentation supports the successful approval of your product.
Core Document Services
Our experienced medical writers work closely with your team to ensure all documents are scientifically accurate, meet global regulatory standards (ICH, FDA, EMA), and support your business objectives.
- Clinical Study Reports (CSRs) and Bioequivalence (CS-BE) Summaries
- Regulatory Submissions (INDs, CTAs, NDAs, BLAs)
- Protocol and Investigator Brochure (IB) Development
- FDA Summary Tables for ANDA Submissions
- Dossier Development for ROW (Rest of World) Markets
Regulatory & Publication Support
Our team, comprising trained statisticians, programmers, and writers, ensures high-quality data analysis and statistical reporting in full compliance with international guidelines. We specialize in:
- Integrated study report writing in eCTD format with hyperlinking and bookmarking.
- Preparation of abstracts, manuscripts, and poster presentations for publication.
- Experienced-based study protocol and ICF (Informed Consent Form) development.
- Custom format reports and patient narratives.
- CD-ROM and hard copy delivery of reports and associated study data.
Our standard reports are meticulously prepared to conform to the requirements of the ICH E3 "Structure and Content of Clinical Study Reports". Our regulatory expertise ensures documentation is written to minimize possible delays in regulatory approvals, a crucial factor in successful medical writing in clinical research.
Ensure Regulatory Approval with Compliant Documentation
Partner with MTRL's expert medical writers for clear, compliant, and submission-ready documents.
Contact Our Medical Writing Team