Medical writing

Medical writing is an integral part of fulfilling regulatory and clinical requirements. Our medical writers work with data provided by our clients and/or perform individual literature searches.

Medical writing

Diapharm provides professional Medical Writing, for example for pre-clinical and clinical expert reports, and dealing with deficiency letters.

Our medical writers provide support with:

• Literature research
• Evaluation of available documents
• Clinical evaluation of medicinal products and medical devices
• Medical writing for pre-clinical tests and clinical trials (e.g. IMPD, study design, study protocol, CRF, study report, final report)
• Medical writing for CTD dossiers: pre-clinical expert reports (CTD modules 2.4 and 2.6) and – clinical expert reports (CTD modules 2.5 and 2.7)
• Summary of Product Characteristics (SmPC) and Patient Information Leaflets
• Assistance with deficiency letters
• Early benefit assessment dossiers
• Medical statements

Clinical affairs

For clinical projects the required documents are developed such as investigational medicinal product dossiers (IMPD), protocols, case report forms or final reports. Our services also include clinical evaluation of medicinal products and medical devices.

As part of development projects, we write development plans, and our extensive experience in the project management of approval projects and in the area of regulatory affairs means that we can analyse the necessary tests and studies and devise intelligent solutions.

For more information visit www.diapharm.com