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:
Please contact OmniScience for further details.