Preparation

Htigh quality medical writing largely contributes to the success of registration of medicinal products. It minimizes the regulatory risk and thus helps to meet project timelines and budget. so if you are going to register a medicinal product or you have already obtained a deficiency etter from the Competent Authority, let us help you

WHAT IS MEDICAL WRITING?

Medical writing for the pharmaceutical industry is a broad term that covers multiple writing services at various level of details, aiming at (but not limited) preparation of dossier for medicinal product approval by Competent Authorities (Regulatory Agencies). This refers to preparation of the entire medical part of the registration dossier, including the parts related to non-clinical data (Module 2.4 Nonclinical Overview, Module 2.6 Nonclinical Summary, Module 4 Nonclinical Study Reports) and clinical data (Module 25 Clinical Overview, Module 27 Clinical Summary, Module 5 Clinical Study Reports) and depending on Specific Requirements for Different Types of Applications (e.g. Modules 15.1 Information for Bibliographical Applications, 1.5.2 Information for Generic, 'Hybrid' or Bio-similar Applications, 15.3 (Extended) Data/Market Exclusivity). Moreover, medical writing services go beyond dossier preparation, involving also the writing of the documents for clinical trials such as clinical study protocols, clinical study reports, subject informed consent forms and investigator brochures.

The inappropriate content and/or format of medicinal product dossier results in allegations of Competent Authorities and, as a consequence, problems in meeting project timelines and budget. Dealing with the requirements of Competent Authorities in the EU as well as outside the EU countries is a challenge that requires vast knowledge, experience and individual approach Regardless of the scope of data to be described, it is common practice for pharmaceutical companies (Marketing Authorizations Holders, MAHs) to outsource medical writing (i.e. dossier preparation) to specialized external companies. At Hub Net Scientific Pharma we provide comprehensive, reliable, detailed medical writing services conducted by experts with appropriate professional education and extensive experience in this field. We prepare medicinal product dossier taking into account state of the art, local requirements, standards within the EU (vide Notice to Applicants (NTA volume 2B) prepared by the European Commission in order to fulfil the article 6 of Regulation (EC) No. 726/2004, and the Annex I to Directive 2001/83/EC) as well as outside the EU. Likewise, in the case of medical writing services such as preparation of clinical trial reports and protocols, we rely on the current guidelines in this field, e.g. on CPMP/ICH/137/95 Note For Guidance on Structure and Content of Clinical Study Report.