This top-20 biopharmaceutical company specializes in the discovery, development, manufacturing, and marketing of medications, with a focus on Oncology, Cardiovascular and Metabolic Disease, Respiratory, Inflammation and Autoimmunity.
Synchrogenix (a Certara company), has been working with this global, top-20 biopharmaceutical company for 10 years. In that time, Synchrogenix has been contracted to support many therapeutic areas, namely Diabetes, Emerging Psychiatry, Central Nervous System (CNS), Cardiovascular, and Oncology. Services offered span the products life cycle from early phase development through post-approval, regulatory defense activities, drug safety, and life cycle management, including ad hoc requests, such as bridging documents and regional payer submissions.
Recently, Synchrogenix was approached by this sponsor to write 6500 narratives in six weeks, based on a post-approval request from the health authorities. A customized process was required to execute the writing, quality control, and medical review of the narratives on time and in compliance with the regulatory agency requirements.