Medical Writing Service
Bringing a drug to market in a timely manner requires clear and informative supporting clinical documentation. The team of experienced medical writers at Intego Clinical produces technical material for projects in all phases of clinical development. We have successfully navigated various regulatory submissions to the EMA and FDA, and also work with our clients to develop informative investigator and patient materials.
Bringing a drug or medical device to market depends on more than compelling clinical data. Incomplete or incorrectly formatted clinical documentation can delay regulatory approval and disrupt company timelines. Intego Clinical has the medical writing expertise available to convert our client’s complex clinical data into the clear and informative documentation international regulatory agencies are looking for.
Our medical writing group consists of regulatory experts with backgrounds in all major therapeutic areas, handling regulatory writing projects across the clinical development cycle. The Intego Clinical writing team works closely with statisticians, clinical data managers and regulatory specialists to prepare technical and scientific documentation for the EMA and FDA.
Intego Clinical offers rapid turnaround to meet client’s internal and external deadlines, with rigorous QC to expedite regulatory submissions and approval.
Our medical writing services:
- Protocol development
- Informed consent forms
- SOPs
- Study design
- Investigator brochures
- CSRs
- EMA and FDA briefing packages
- Periodic safety update reports, periodic risk-benefit evaluation reports
- Regulatory submission documents
- NDA/sNDA, MAA, PMA, 510(k) and CTD technical summaries
- Abstracts and posters
