Aclairo®’s regulatory and scientific writers have extensive experience in researching and writing regulatory documents and position papers. We will work with you to meet your specifications and timelines using your templates and style guide, or our own, to create submission-ready documents. We follow SOPs to ensure consistently high quality documents and conduct a quality control (QC) review of each document. Our regulatory writing services include:

• Regulatory Submissions
• Regulatory applications for the FDA and Europe
• Special Protocol Assessments (SPAs)
• Investigator Brochures (IBs)
• Legacy or CTD formats
• INDs, CTDs, and NDAs
• Technical and scientific review and QC checks of regulatory applications
• Primary research manuscripts, position papers and white papers for preclinical research publications
• Literature reviews and summaries
• Subject-specific literature searches
• GLP study reports
• Quality control review of each document
• FDA meeting packages

For more information, please contact: Parthena Martin (pmartin@aclairo.com)