Medical writing

Languageweb24 is a leading provider of specialized services for the pharma, biotech and medical device industries.
Whether you are looking for medical-scientific services: Writing expert opinions and expert statements on pharmacology-toxicology and clinical issues, final reports of clinical studies, general medical-scientific texts, etc.
We got you covered!
We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results - going above and beyond the standard to deliver tailor-made solutions worldwide.

Regulatory Affairs Consultant Services

Clinical studies:

Clinical study protocols
Investigational medicinal product dossier (IMDP)
Investigator’s brochure
Clinical study report (CSR)
Informed Consent Form, Case Record Form, Patient Diary

Marketing authorization dossier:

Expert reports on the pre-clinical section (CTD modules 2.4, 2.6, 4)
Expert reports on the clinical section (CTD modules 2.5, 2.7, 5)
Patient information leaflet (PIL)
Summary of product characteristics (SmPC)
Concepts and drafts for clinical studies
Summary of clinical studies
Clinical study protocols
Clinical study reports
Supplements to study protocols and reports
Writing of expert reports and expert statements on pharmacology/toxicology and clinical trials, final reports of clinical trials, general medical-scientific texts, etc.

Navigating the Labyrinth: Your Guide to Streamlined Medical Writing and Regulatory Success
The world of pharmaceutical, biotech, and medical device development is a complex one. Just getting your product to market can feel like navigating a labyrinth, with regulations, documentation, and deadlines constantly looming. Languageweb24 is here to be your guide, offering a comprehensive suite of medical writing and regulatory affairs consultant services to ensure a smooth and successful journey.
From Concept to Approval: We Cover Every Step
Whether you’re a seasoned developer or just starting your journey, Languageweb24 has the expertise to support you at every stage. Our team of medical writing specialists and regulatory affairs consultants possess a deep understanding of the industry and the intricacies of regulatory requirements.
Medical Writing Expertise Tailored to Your Needs

Clinical Documentation: We craft clear, concise, and scientifically sound documents that meet the highest standards, including clinical study protocols, investigator’s brochures, clinical study reports, and informed consent forms.
Regulatory Documents: Our team ensures your marketing authorization dossiers are complete and compliant, with expert reports on pre-clinical and clinical sections, patient information leaflets, and summaries of product characteristics.
Scientific Communication: We excel at translating complex scientific data into clear and compelling communication for a variety of audiences, from healthcare professionals to patients. This includes crafting expert reports, scientific presentations, and educational materials.

Regulatory Affairs: Your Partner in Compliance
Our regulatory affairs consultants provide invaluable guidance throughout the development process. We offer:

Strategic Planning: We work with you to develop a clear roadmap for your product’s journey, ensuring all regulatory requirements are met efficiently.
Non-Clinical and Clinical Support: We assist with navigating the complexities of non-clinical and clinical development, including gap analysis and preparation of essential documents.
Post-Approval Support: Our services extend beyond initial approval, with expertise in pharmacovigilance and maintenance of regulatory documentation.

Technology-Driven Solutions for Efficiency
Languageweb24 leverages cutting-edge technology to streamline the process and ensure quality. Our tools enable us to:

Enhance Accuracy: Utilize text mining and data analysis for in-depth scientific evaluation and literature research.
Optimize Workflows: Streamline document creation and management, ensuring consistency and efficiency across all deliverables.
Maintain Compliance: Our technology supports the creation and maintenance of SOPs (Standard Operating Procedures) to guarantee regulatory adherence.

The Languageweb24 Advantage: Exceptional Results, Tailored Solutions
We go beyond simply providing services; we become a trusted partner in your success. Our core values define our approach:

Exceptional Quality: We deliver meticulous, error-free work that meets the highest scientific and regulatory standards.
Tailored Solutions: We understand that one-size-fits-all doesn’t apply. We work closely with you to customize our services to your specific needs and project goals.
Global Expertise: Our team has extensive experience across a wide range of therapeutic areas and regulatory landscapes.
Unwavering Dedication: We are committed to your success and work tirelessly to ensure your project stays on track and meets deadlines.

Partnering with Languageweb24 means navigating the complexities of medical writing and regulatory affairs with confidence. Contact us today to discuss your specific needs and let us guide you towards a successful product launch.

Languageweb24 Medical Writing Services

Clinical Study Documents
- Development Plans
- Clinical Study Protocols
- Investigator’s Brochures
- Clinical Study Reports
- Informed Consent Forms
- Case Report Forms
- Patient Diaries
- Supplements to Study Protocols and Reports
Regulatory Documents
- Marketing Authorization Dossiers
- Expert Reports (Pre-clinical & Clinical)
- Clinical Overviews & Summaries
- Patient Information Leaflets (PILs)
- Summaries of Product Characteristics (SmPCs)
- Environmental Risk Assessments (ERAs)
- Reference Safety Information
- Risk Management Plans
Scientific Communication
- Medical and Scientific Texts (for various audiences)
- Scientific Publications (research reports, essays)
- Training Materials & Marketing Support Materials
- Slide Decks, Abstracts & Posters
- Quality Checks for Medical Accuracy
- Expert Statements (Clinical & Pharmaceutical)
- Medical/Scientific Claims Advice (for products)
Regulatory Affairs Support
- Strategic Planning for Development
- Non-Clinical & Clinical Study Support (incl. GAP analysis)
- Preparation of Study Data (incl. literature research)
- Instructions for Use (Package Leaflets) & SmPCs
- Traditional Documents (herbal medicinal products)
- Briefing Documents for Scientific Advice
- Labeling, SmPC & Package Leaflet Creation (according to regulations)
- Review of Professional/Lay Advertising & Presentations
Additional Services
- Preparation and maintenance of SOPs (Standard Operating Procedures)
- Support with publications and press releases
- Documentation of scientific/clinical evidence (diagnostics)
- Training courses and lectures
- Literature research and information procurement
- Creation of scientific texts, abstracts, and approval document modules
- Vigilance reports (PSURs)

Expert reports on the pre-clinical section
CTD modules 2.4, 2.6, and 4
CTD modules 2.4, 2.6, and 4 refer to specific sections of a document used for regulatory submissions in the pharmaceutical industry called the Common Technical Document (CTD). The CTD is a standardized format used to organize all the data and information needed to get a new medicine approved for marketing by regulatory agencies around the world.
Here’s a breakdown of the modules:

Module 2.4: Safety Pharmacology
- This module focuses on studies that assess the effects of a medicine on the body’s vital functions, such as heart rate, blood pressure, and breathing. It’s important to ensure the medicine doesn’t cause unintended harm to these vital systems.
Module 2.6: Pharmaceutical Toxicology
- This module contains information about studies that assess the potential for toxicity (harmful effects) of a medicine. These studies are typically conducted in animals and explore how the medicine is absorbed, distributed, metabolized (broken down), and eliminated from the body. They also investigate potential adverse effects at different dose levels.
Module 4: Nonclinical Study Reports
- This module contains the full reports of all the non-clinical studies mentioned in modules 2.4 and 2.6. These reports provide detailed information about the study design, methods, results, and conclusions.

In summary, CTD modules 2.4, 2.6, and 4 together provide a comprehensive picture of the safety profile of a medicine based on preclinical studies (studies conducted in animals before human testing).

CTD modules 2.5, 2.7, and 5 deal with the clinical side of a drug’s development, focusing on studies conducted in humans. They work together to present a clear picture of the drug’s efficacy (effect...

Expert reports on the clinical section
CTD modules 2.5, 2.7, and 5
CTD modules 2.5, 2.7, and 5 deal with the clinical side of a drug’s development, focusing on studies conducted in humans. They work together to present a clear picture of the drug’s efficacy (effectiveness) and safety in humans. Here’s a breakdown of each module:

Module 2.5: Clinical Overview
- This module provides a concise, high-level summary of the clinical data supporting the application for the medicine. It highlights the key findings from the clinical studies (Modules 5) regarding the drug’s efficacy, safety, and proposed dosage.
- Think of it as the "executive summary" for the clinical aspect of the drug’s application, targeting reviewers who might not have time to delve deeper into the details.
Module 2.7: Clinical Summary
- This module goes into more detail than the Clinical Overview. It provides a structured and integrated analysis of all the clinical studies conducted on the medicine. This includes information on:
  - Study design and methodology
  - Patient demographics and baseline characteristics
  - Efficacy data (how well the drug worked)
  - Safety data (adverse effects experienced by patients)
  - Discussion of the overall clinical findings
Module 5: Clinical Study Reports
- This module contains the full reports of all the clinical trials conducted on the medicine. These reports provide a comprehensive and detailed record of each study, including:
  - Objectives and methodology of the study
  - Description of the study population
  - Data collection methods and statistical analysis
  - Results of the study, including both efficacy and safety data
  - Discussion of the study findings and their limitations

In essence, CTD modules 2.5, 2.7, and 5 provide a roadmap for understanding the clinical development of a medicine. They offer a tiered approach, starting with a high-level overview (2.5) and progressing to a more in-depth analysis (2.7) supported by the raw data from the individual studies (Module 5)