Medical Writing
Medical writing undoubtedly plays a crucial role in the success or failure of new compounds.
Medical writing domain help to compile, organize, write, edit and produce a number of medical and scientific documents essential to deliver the quality and timeliness required to support the product development process.
Our clients are offered with any stage in their product development lifecycle – from clinical development plan and investigator brochures to regulatory submission and licensing maintenance documents. The expertise from PK|PD to pharmaco-vigilance, are capable to work on study reports, patient narratives, DSMB updates, labeling or other documents involving study data.
The Medical Writing services is proficient in
- Abstracts, manuscripts and journal articles
- Investigator brochures and annual updates
- Informed consent forms and CRFs
- Protocols
- Clinical study reports
- Clinical sections of Common Technical Documents (CTDs)
- Clinical sections of New Drug Applications (NDAs)
- Periodic Safety Update Reports (PSURs) and other pharmaco-vigilance documents
- Pre-FDA meeting briefing documents
- Preclinical study reports, expert reports and summaries
- Data Safety Monitoring Board (DSMB) manuals
Bio-Analytical Reporting
- Method Validation Reports
- Bio analytical Reports
- ISR Reports
- Submission-ready Documentation (Hyperlinked eCTD formatting)
- Dispatch & Archival
- Benefit | Risk assessment reports apart from medical and scientific literature reviews
Our unique medical writing offerings are in strict adherence with ICH guidelines and similar regulatory requirements.