HIGH-QUALITY MEDICAL WRITING AND PROJECT MANAGEMENT

Complete Regulatory is a specialist team of experienced regulatory writers who provide a consistently high level of quality and flexibility. We deliver medical writing and project management services that ensure the timely provision of high-quality, submission-ready documentation. The types of document we support cover all phases of drug development, from the first study in man through to marketing approval and lifecycle management. We remain on hand to assist with responding to regulatory questions after submission. We have been involved with successful registrations in Europe (EMA), the US (FDA), and Japan (PMDA) across many therapeutic areas.

We have a sound understanding of current and emerging regulatory guidelines/requirements; experience in a wide range of therapeutic areas; and in-depth knowledge of non-clinical and clinical data evaluation, medical statistics, and pharmacokinetics. This, combined with our quality-control procedures, enables us to produce high-quality documents that meet your exact requirements.

  • CLINICAL DEVELOPMENT

    Across all phases of clinical development we provide the required supporting documents, such as protocols, informed consent forms, investigator’s brochures, investigational medicinal product dossiers and pediatric investigation plans.

  • CLINICAL STUDY REPORTS

    Once a study is complete, we develop the clinical study reports (Phases I to IV), prepare patient narratives, and prepare documents for clinical disclosure.

  • CLINICAL SUBMISSIONS

    For a new submission, we can provide a team to produce the clinical submission documents such as the clinical overview and clinical summaries, and risk management plans.

    We remain on hand to assist with responding to regulatory questions after submission.

  • REGULATORY BRIEFING DOCUMENTS

    During development, we prepare regulatory briefing documents and questions, as well as internal briefing documents to enable decision-making.

  • CHEMISTRY, MANUFACTURING AND CONTROLS

    We support the production of chemistry, manufacturing and controls regulatory documentation.