Medical Affairs for CTD and Expert Reports
At Diapharm we coordinate on behalf of our clients the entire medical part of the marketing authorisation procedure and prepare all relevant documentation (preclinical and clinical expert reports, medical assessments). In close collaboration with the Clinical Management and Pharmacovigilance divisions, Diapharm offers its clients a complete package service, assuming comprehensive medical and scientific charge of their medicinal products.
| Medical Affairs |
| Medical assessments |
| Preclinical expert reports (pharm.-tox.) |
| Clinical expert reports |
| CTD Modules 2.4 to 2.7 |
| Clinical evaluation of medical devices |
From compilation of Investigational Medicinal Product Dossiers (IMDP) right up to postmarketing surveillance and pharmacovigilance for medicinal products already approved, Diapharm can coordinate all phases of preclinical and clinical development and subsequent drug monitoring. The Medical Affairs specialists will process medical and scientific information derived from studies and literature and draw up medical assessment reports.
For registration dossiers the medical and scientific data are used to prepare electronic Common Technical Document (eCTD) modules. These contain reviews of preclinical work comprising pharmacology, pharmacokinetics, and toxicology (CTD Module 2.4) as well as reviews of the clinical stage of the work: biopharmaceutics, clinical pharmacology, efficacy, safety and a risk-benefit analysis (CTD Module 2.5). The Medical Affairs experts will also provide summaries of the preclinical and clinical studies (CTD Modules 2.6 and 2.7 respectively).
In addition to this, Diapharm offers a clinical evaluation service for medical devices, relating to their use, mode of action, etc., required for the technical documentation of medical devices. Such clinical evaluation is indispensable for certification as a medical device.
