Medical writing

Correct scientific information saves lives

Qplus consult writes all your medical and regulatory documentation

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Medical writing for Regulatory Affairs, and medical and marketing communication.

An increasing number of research studies and growing clinical experience result in new knowledge and information on medicinal products, medical devices, food supplements and cosmetics. All this information must be effectively communicated to different target groups, such as health care professionals (HCP), patients, consumers, regulators and internal employees like sales representatives.

Qplus consult understands the importance of clear, concise and precise medical writing.

Our team of medical writers has the expertise to understand and analyse complex information. They prepare scientific documents and publications in accordance with relevant and applicable guidelines and standards expected by regulators. Our experts strictly follow internal procedures or apply our client’s specific procedures and templates in order to ensure the highest quality.

Our structure and philosophy guarantees your success.

Diversity: Medical Writing team members have diverse educational and professional backgrounds, with qualifications in medicine, pharmacy, or life sciences and previous experience in pre-clinical research, clinical laboratory, study coordination, Regulatory Affairs (RA), data management and scientific writing.
Flexibility: Our document preparation process involves experts from RA and Medical Affairs who are readily accessible for review and feedback, and proactively provide solutions.
Communication: When drafting a medical document, contact is maintained with our other cross-functional areas like marketing and regulatory. We also maintain strong communication with you to ensure your first draft is consistent with your expectations.
Quality: Internal quality control reviews at each development step ensures accuracy and consistency. Additionally, senior management plays an active role throughout the review process.

Qplus consult provides medical writing services in the following therapeutic areas

Cardiovascular Dermatology Metabolic and endocrine disorders Gastroenterology Haematology and oncology Infectious diseases
Neuroscience and pain management  Ophthalmology Respiratory Urology

Medical education material

Medical education material is an additional risk minimisation measure designed to promote the safe and effective use of the medicinal product. Although not required, it’s provided to healthcare professionals (HCP) and/or patients and care-givers if deemed helpful in optimising the safe and effective use of the product.
Contact us to find out how we can assist you.


Scientific poster (content and lay-out)

Posters are a popular presentation format for research and clinical vignettes. They efficiently communicate concepts and data to an audience using a combination of visuals and text and give investigators the opportunity to present their work at scientific meetings and prepare for publication in a journal. Qplus consult lets you communicate your services effectively with profesionally designed posters.
Contact us to find out how we can assist you.


Scientific articles including abstracts

A scientific article is the work that an author submits to a publisher, editor, or producer for publication. Although it is a crucial step in the communication of study results to the scientific community, many investigators lack the experience or simply don’t have the time to create an article fulfilling all expected quality standards. Our experienced Medical Team assists you in writing scientific articles, including abstracts, respecting the publisher’s guidelines.
Contact us for more information or a free appointment.


Training Material

Our Medical Team develops training material to your needs if physicians, pharmacists, patients, employees like medical representatives, or other stakeholders need clarification on a product’s properties (development history, active substances, indications, pharmacokinetics,…). Scientific and evidence based facts are presented in a concise and attractive way to elucidate your product to laypersons.
We also provide the training to all relevant stakeholders. To your preference, this can be done online via Webinars, Quastion Learning Services and Webcast Studio, or offline in facilities of your choice or those of Qplus consult at Zaventem.

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Medical Document

Our experts draft medical documents that help you in making correct marketing and investment decisions, and form the backbone of future regulatory documents. The content can be adapted to your needs elucidating the indication’s definition and classification, prevalence, epidemiology and impact, risk factors and comorbidities, prognosis, pathophysiology, diagnosis, management and treatment options, and patient journey.

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Summary of Product Characteristics (SmPC)

The Summary of Product Characteristics (SmPC) is a key document that informs healthcare professionals (HCP) on how to use a medicinal product and its safety information. The content is updated throughout the product’s life-cycle as new data emerges. When submitting a new application for registration, renewal or variation, the SmPC must be presented in a format approved by the authorities. Qplus consult helps you with the creation of, or adjustments to this document in line with all regulatory requirements. While the content stays easily accessible and understandable for HCP.

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Patient Information Leaflet (PIL)

The Patient Information Leaflet or PIL is based on the Summary of Product Characteristics (SmPC) and communicates information on the safe use of the medicinal product to the patient. Like the SmPC, the PIL must be approved by the authorities at the time of a marketing authorisation, renewal or variation. Our Medical Team drafts the PIL of your medicinal products in compliance with all regulatory requirements and yet easily accessible and understandable for the patient.

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Company Core Data Sheet (CCDS)

A Company Core Data Sheet (CCDS) is an internal document prepared by the Marketing Authorisation Holder (MAH) that next to safety information bundles material relating to indications, dosing, pharmacology, and other information concerning the medicinal product. A CCDS ensures aligned labelling around the world and presents the ‘reference safety information’. The creation of this document and keeping it up-to-date forms quite the challenge for many companies due to its complexity and cross-functional character. Our Medical Team has experience in drafting and adapting a product’s CCDS in line with all regulatory requirements.

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Common Technical Document (CTD) Module 2: clinical and non-clinical sections

The Common Technical Document (CTD) is a set of specifications to prepare the application dossier for the registration of medicinal products for human use. The format was developed and mutually agreed upon by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, U.S.) and the Ministry of Health, Labour and Welfare (Japan). The CTD is organized into five modules. Module 2 includes all clinical and nonclinical summaries and overviews. Qplus consult has successfully supported different clients in preparing these sections for product registration, either updating an older authorisation dossier or drafting a complete new one.
Contact us if you want assistance or more information.


Summary of Clinical Efficacy

The Summary of Clinical Efficacy includes a tabular listing of all studies that provided information relevant to the efficacy of the medicinal product, a brief overview of the design these studies, and an analysis of efficacy results across the studies. It is essential that the Summary of Clinical Efficacy is presented in the correct way and that information supporting the label is well organised, traceable and understood in preparation for regulatory defence questions. Our experts help you save time and money, let you make effective decisions and deliver clear messages supporting the target product claims.
Contact us now to find out how they can assist you.


Summary of Clinical Safety

The Summary of Clinical Safety summarises all data relevant to safety in the targeted patient population, integrating the results of individual clinical study reports and other relevant reports. Thanks to our experience you can save considerable resources, time and money by carefully planning how the summaries are structured and delivering clear messages supporting the target product claims.
Call or email us for a free appointment to find out what we can do for you.


Clinical Overview

The Clinical Overview is an important part of the Common Technical Document (CTD). It is a valuable resource for medical assessors to familiarise themselves with the scope and rationale of the applicant and the critical issues in the clinical development program. Qplus consults creates your clinical overview and summary in accordance with the regulatory expectations.
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Periodic Safety Update Report (PSUR)

The goal of the PSUR is to present an exhausting and critical analysis of the risk-benefit balance of your medicinal product, taking into account newly emerging and historical safety information. Hence, the PSUR is updated on an ongoing basis and at defined time points after product’s authorisation. This document is mandatory for both centrally and nationally authorised products. Our medical writers and PV experts assist you with the preparation and writing of your PSUR, making sure you comply with all European standards and requirements as defined in the Good Pharmacovigilance Practice (GVP) guidelines.
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Narratives

Narratives are brief summaries of specific events experienced by patients, during the course of a clinical trial. They are submitted to the regulatory authorities along with the clinical study reports to establish any causal relationship between the events experienced by the patient and the drug under investigation. Our expert team understands the expectations of the regulatory authorities and can help you writing and submitting your patient safety naratives in a cost-efficient way.
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Investigational Medicinal Product Dossier (IMPD)

The Investigational Medicinal Product Dossier (IMPD) is one of the essential documents that form the Clinical Trial Application (CTA) submitted to the competent authorities. It includes summaries of information related to the quality, manufacture  and control of any investigational medicinal product,  data from nonclinical studies and clinical studies, and the product’s phase of development. Qplus consult has a proven recordof writing and assembling IMPD for different types of medicinal productsresulting in swift acceptance of Clinical Trial Applications by competent authorities.
Contact us today for more information.


Clinical Study Report (CSR)

The Clinical Study Report (CSR) is a crucial document in the regulatory submission process. It represents the most complete synthesis of the planning, execution and results of a clinical trial. The experience of our medical writers in drafting these reports ensures a high quality end result that meets all standards.
Call or email us if you need assistance in writing or submitting a CSR.


Briefing document

Briefing documents are used to respond to questions of health authorities and to communicate with Healthcare Professionals (HCP), presenting critical information in a concise and professional manner. Qplus consult has extensive experience assisting clients with their communication to authorities and HCP. We understand that clear and structured messages help them to make better and faster decisions.
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Risk Management Plan (RMP)

A Risk Management Plan (RMP) includes information on the safety profile and plans for pharmacovigilance (PV) activities of a medicinal product. The plan elucidates how potential risks will be minimised. Submission is required for marketing authorisation applicants. The scope, form and documentation used in pharmaceutical risk management should be tailored to suit the specific risks in question. Qplus consult has years of experience in developing risk management plans and measures for products from various therapeutic areas. Contact us today.


Paediatric Investigation(al) Plan (PIP)

A Paediatric Investigation Plan (PIP) is a development plan designed to ensure that the necessary data is obtained through studies in children to support the authorisation of a medicinal product for infants, children and adolescents. For all new medicinal products seeking marketing authorisation, this plan and/or a waiver must be agreed in advance with the European Medicines Agency (EMA). As with all regulatory documents, realistic planning of resources and timelines is crucial to the success of preparing the PIP.
Let our experts help you. Contact them now.


Benefit-Risk Assessment Report

The assessment of the Benefit Risk Report of a medicinal product is a complex activity that sponsors and regulators perform throughout the product life cycle. In order to improve the transparency and consistency of the decision-making process, regulators and sponsors are increasingly adopting a structured approach to the Benefit Risk Assessment Report. For regulators, this document is vitally important in making the determination as to whether or not a marketing application is worthy of approval. Qplus consult has extensive experiencein writing the various components of marketing applications, including Benefit-Risk Assessment Reports, across a wide range of therapeutic fields.
Contact us for more information or a free appointment.

Medical and regulatory documentation developed by our experienced writers play a crucial role in the success of your project.

Maximize the impact of your written documents

Call +32 (0)2 889 05 68

or

Send an email