Medical writing – preparation of registration dossier
High 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 letter 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 2.5 Clinical Overview, Module 2.7 Clinical Summary, Module 5 Clinical Study Reports) and depending on Specific Requirements for Different Types of Applications (e.g. Modules 1.5.1 Information for Bibliographical Applications, 1.5.2 Information for Generic, ‘Hybrid’ or Bio-similar Applications, 1.5.3 (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.
Medical writing outsource
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.
Medicinal product dossier – well prepared, easily approved
At SciencePharma 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.
We have a broad experience in medical writing services for the distinct locations (e.g. in European Economic Area (EEA), Eurasian Economic Union (EAEU), Middle East and North Africa (MENA), US, Canada, UK and other third countries) – we have already prepared over 500 documentations for medicinal products, getting familiar with the requirements and expectations of Competent Authorities in different countries.
Based on the data provided by the Client (i.e. chemical and pharmaceutical data, results of own studies), as well as published literature, we can prepare the complete medicinal product dossier in appropriate format, compile eCTD sequence and submit the documentation to Competent Authority. Within the service of medical writing, we can prepare non-clinical and clinical parts of medicinal product dossier. Our extensive experience results from years of work on served medical writing for an excellent variety of products:
- Generic medicinal products with BE study as well as BE study waiver reports,
- Hybrid medicinal products,
- Fixed dose combination medicinal products (FDC),
- Herbal medicinal products,
- Well-established use (WEU) medicinal product (both single- and multi-component),
- Biological medicinal products (including biosimilars),
- Original medicinal products.
Why is it better to outsource medical writing to SciencePharma? What dangers can you avoid?
At SciencePharma, medical writing services are provided by highly educated top class experts of various scientific background in pharmacy and biological sciences (many with a doctoral degree) experienced in academic area as well as pharmaceutical industry. Our vast practice allows us to avoid the pitfalls of inexperienced medical writers such as improper selection of scientific publications and/or guidelines, improper scope of data from own research in the documentation or the wrong manner of presenting these data, and in general – non-compliance of the content of the modules with the CTD format. In SciencePharma we know how important the quality of data is, that’s why we carefully search for, effectively analyze and select the data and provide appropriate discussion and compilation of the available data.
Knowledge of both general and active substance-specific or disease-specific guidelines is for us a fundamental issue to properly assess and discuss available data. Although the general dossier structure in different countries may be similar, individual Agencies may differ in their expectations regarding the content of dossier for particular substances or types of application. Knowing this, we are able to optimize dossier writing in order to facilitate the smooth registration of the product on specific market. A proof of high effectiveness of our services in this field is a low rate of Competent Authorities’ allegations relating to medical writing itself for medicinal product dossier. If any allegations occur, we address them promptly, to avoid delay in registration process.
Benefit of cooperation
Thanks to people with a diverse scientific background in the MED and CMC departments (pharmacists, biologists, biotechnologists, chemists), we are capable of preparing complete registration dossier for medicinal products. At RA department, we can assist MAHs in the process of submission of documentation, and in next steps, our PV department can perform pharmacovigilance services for the registered medicinal product. Isn’t it convenient to have all these services provided comprehensively at an expert level in one place?
- Would you like to register a medicinal product, but you do not know which documents are essential?
- Want to prepare a high quality medicinal product dossier, but you do not know how to present the data to meet regulatory requirements?
- Want to prepare a protocol or report from a clinical trial? Investigator brochure? Informed consent form?
- Not sure whether the dossier have been prepared appropriately?
If any of these questions came to your mind, you have just found a reliable partner that will provide you with the solution which exactly meets your expectations.
As medical writing is often associated with other services, let us know if you need help in:
- Analyses of registration possibilities of medicinal products (including the choice of optimal type of application),
- Opinions regarding the possibility of Rx-to-OTC switch,
- Postmarketing variations (e.g. addition of indication, Rx-to-OTC switch),
- Gap analysis or audit of already prepared dossier,
- Planning and conducting of clinical trials,
- Paediatric Investigation Plans (PIPs).