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.

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