REGULATORY WRITING SERVICES

Provenance offers our services to clients who wish to get their regulatory documents written by qualified and experienced medical writers at competitive price. Provenance offers expertise in handling regulatory documents from protocol to safety reports. Provenance has proficiency in:

• Clinical protocol writing
• Investigator brochure writing
• Investigational New Drug (IND) Applications and Investigational Medicinal Product Dossiers (IMPDs) writing
• Clinical study reports
• Safety narrative writing
• Periodic safety reports: ASRs, Periodic Safety Update Reports (PSURs)and US Periodic report
• Case report forms (CRF) designing
• Abstracts and Manuscripts
• Informed Consent Forms
• Posters and Presentations
• Literature reviews and searches