Regulatory Writing

Mercury Medical Communications, Inc. produces regulatory documentation (phase 1 through 4), including INDs/NDAs, clinical protocols, investigator brochures, and clinical study reports.

Mercury has extensive experience preparing clinical trial protocols and study reports according to
FDA, ICH (International Conference on Harmonization), and GCP standards and guidelines.

Mercury has considerable experience preparing common technical documents (CTD)
according to ICH standards, for new market authorizations, prescription to OTC-switches, line extensions, orphan indications and applications for drugs with well-established use.

Mercury can write whole sections or parts of sections, and depending on our clients’ needs, add to existing files, edit, update, and prepare dossiers in paper form or as fully hyperlinked electronic common technical documents (eCTD). Mercury works with the client's template or our own, and based on ICH guidelines, will modify it for new market authorizations, as well as late-stage products, OTC-switches, and orphan drugs.