regulatory affairs

We are fully acquainted with drug regulatory and clinical research guidelines (ICH, EMEA, FDA).

OmniScience provides a range of writing services for regulatory bodies. We work with clients’ templates according to their style conventions or use our own templates based on ICH guidelines.

OmniScience specializes in compiling regulatory documents for the pharmaceutical industry and provides the full range of non-clinical and clinical regulatory documents. Our regulatory medical writing experience includes a variety of regulatory submissions ranging from Investigative New Drugs (INDs) to products with Well-Established Use. We have particular experience in:

• Writing and compiling non-clinical and clinical CTD modules (Non-clinical and Clinical Expert Statements)
• Providing quality-assured eCTD-compliant non-clinical and clinical modules
• Compilation of NeeS
• Investigator Brochures
• Clinical Study Protocols
• Clinical Study Reports
• Briefing Books and Replies to Authorities
• Safety Issue Work-Ups (IWU)
• Toxicology reports
• Investigational Medicinal Product Dossier (IMPD)
• Summaries of Product Characteristics (SmPCs), Patient information leaflets (PIL)
• IND applications
• Core Data Sheets (CDS)
• Clinical trial summaries

Please contact OmniScience for further details.