regulatory documents

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

OmniScience specializes in producing a range of documents for submission to regulatory authorities (national, EMA, FDA). We work with clients' templates according to their style conventions or use our own ICH guideline-based templates and style guide.

We offer support from early clinical development through to post-marketing. We have experience in compiling the non-clinical and clinical overviews and summaries for Investigative New Drugs (INDs) and drugs of Well-Established Use (OTC). 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 overviews and summaries
• Clinical and non-clinical expert summaries
• Investigator Brochures
• Clinical Study Reports
• Risk Management Plans
• Briefing Books
• Replies to Authorities
• Toxicology reports
  (including Independent Assessments)
• Investigational Medicinal Product Dossiers (IMPD)
• IND applications
• Clinical trial summaries

Please contact OmniScience for further details.