MEDICAL WRITING
What is Medical Writing and how to choose the service provider?
Medical Writing is a vital activity across all stages of pharmaceutical product development. By crafting comprehensive and detailed documentation tailored to every aspect of the product, it helps define its characteristics and ensures compliance with regulatory requirements. The primary goal is to enhance understanding of a particular medicine, facilitating its safe and effective use while serving as a key communication tool with regulatory authorities.
Selecting a reliable and competent Medical Writing provider is essential for ensuring proper product management. Our team of highly qualified professionals offers comprehensive support, backed by extensive experience and ongoing adherence to international directives and regulations.
Our extensive experience in this field enables us to tackle the challenges of complex projects and meet the specific needs of clients while ensuring the highest standards of quality in the industry.
OUR SERVICES
Common Technical Document (CTD)
Our service for drafting and reviewing the Common Technical Document (CTD) ensures a thorough and meticulous analysis of pharmaceutical product characteristics, in full compliance with existing regulations. The guidelines defining the structure and content of the CTD have facilitated the development of a standardized format for documentation required in new drug registration requests. This standardized format streamlines the management of essential information, facilitating efficient communication with Regulatory Authorities through the electronic Common Technical Document (eCTD).
The CTD dossier is organized into five main modules. Our team of specialists excels in compiling:
- Module 1
This module, named Administrative Information and Prescribing Information, contains region-specific documents such as registration forms and proposed labels tailored to each geographic area. VI.REL Pharma ensures absolute compliance with diverse Authority requirements through our dedicated international team.
- Module 2
Module 2 presents various product characteristics, including pharmacological class, mechanism of action, and proposed clinical applications. It’s further divided into sections providing comprehensive insights into different product facets. The Non-Clinical Overview and Non-Clinical Written and Tabulated Summaries offer an in-depth examination of non-clinical data on pharmacology, pharmacokinetics, and toxicology, alongside their clinical implications.
Conversely, the Clinical Overview and Clinical Summary focus on analyzing clinical data and integrating findings. These sections encompass bio-pharmaceutics, clinical pharmacology, efficacy considerations, and risk/benefit assessments.
Module 4
The Non-Clinical Study Reports module encompasses non-clinical documentation within the dossier, categorized into specific sections covering pharmacology, pharmacokinetics, and toxicology.
Module 5
The Clinical Study Reports module presents clinical documentation within the dossier, organized into sections detailing reports from clinical studies. These sections delve into aspects of bio-pharmaceutics, pharmacokinetics, pharmacodynamics, efficacy, and safety, providing comprehensive insights into the product’s clinical profile.
VI.REL Pharma, leveraging the extensive experience of his specialist team and conducting thorough and precise data analysis, provides comprehensive and effective support throughout the compilation, management, and submission of the CTD dossier.
Environmental Risk Assessment (ERA)
The Environmental Risk Assessment (ERA) is a comprehensive document evaluating potential environmental risks associated with medicinal products, their environmental impact, and outlining specific strategies to mitigate them. According to European directives, this dossier is a mandatory inclusion in applications for marketing authorization of medicinal products for human use. VI.REL Pharma, with his team of specialists, offers thorough consultancy services for drafting and submitting this document, ensuring its integrity and full compliance with current regulations.
Addendum to the Clinical Overview
The Addendum to the Clinical Overview (Addendum, AddCO) offers vital insights into the safety and efficacy of a pharmaceutical product and is a requisite submission to Regulatory Authorities during the renewal of marketing authorization (MA). This document should include a critical discussion addressing the current benefit-risk profile of the product, drawing from new safety and efficacy data accumulated from initial authorization to renewal. Factors such as Periodic Safety Update Reports (PSURs), reports on suspected adverse reactions, additional pharmacovigilance activities, and the effectiveness of risk minimization measures outlined in the Risk Management Plan (RMP) are considered.
VI.REL Pharma, backed by a team of seasoned professionals, specializes in crafting and submitting the Addendum to the Clinical Overview (Addendum, AddCO), ensuring a meticulous and comprehensive analysis of the benefit-risk profile by clinical experts.
Scientific publications
VI.REL Pharma provides a comprehensive consultancy service for the drafting and publication of scientific articles.
With our highly qualified and competent team, we ensure professional management throughout all stages of article writing. Our collaborative approach involves crafting the best publication strategy, identifying target journals for submission. Through meticulous literature research and careful data analysis, using the most appropriate statistical analysis tools, we proceed with drafting the scientific article. The draft then undergoes a rigorous review process to correct all formal and substantive aspects, aligning with the editorial standards of the target journal. Furthermore, our team of experts handles submission and monitors publication, promptly addressing any reviewer comments.
Pharmaceutical promotional material
Our consultancy service for promotional materials ensures strict adherence to current European regulations, delivering effective and precise communication. With our deep expertise in scientific and regulatory domains, we meticulously evaluate all pertinent information, ensuring alignment with the specifications outlined in the Summary of Product Characteristics (SmPC). Led by a medical professional or pharmacist, our scientific team approves promotional materials, guaranteeing the accuracy of the information presented. Furthermore, we offer support in drafting Abbreviated Prescribing Information (API) and handling notifications or submissions to Competent Authorities in accordance with national requirements.
