Medical Writing

All new medical products go through the increasingly complex process of clinical trials and regulatory procedures leading to market approval. This leads to the demand for well-written, standard-compliant documents that medical professionals can read and understand easily and quickly. Our expert team of medical writers has the skills required to produce well-structured documents that present information clearly and concisely. This service includes regulatory/clinical medical writing of documentation required in the regulatory approval process of your drugs, devices, in vitro diagnostics, or biological products. But also educational medical writing to deliver documents for both general and specific audiences, such as healthcare professionals. For example: literature studies, clinical study protocols, clinical evaluation plans (CEP) and reports (CER), clinical study reports (CSR), patient-informed consent forms (ICF), investigator brochures (IB), Investigational Medicinal Product Dossiers (IMPD), Performance Evaluation Plans (PEP) and reports (PER), etc.