Landoor has long been a trusted provider of excellent medical writing services for the most renowned and prestigious scientific publishers, pharmaceutical companies and medical device manufacturers, and devotes a large part of its Editorial Division to the writing/editing of scientific documentation for regulatory authorities, on the one hand, and the target audience (doctors, healthcare workers, patients, consumers of pharmaceuticals and medical products and users of medical devices) on the other. In 2021 it also forged a high-profile partnership with a leading medical writing company based in the UK in order to meet the needs of its clients and the scientific community involved in global projects, clinical research and the development of vaccines for coronavirus, among other things.

Landoor’s mission in the medical writing field is to facilitate the progress of medical research by providing high-quality scientific documentation while respecting the time constraints and budgets of its clients.

Our medical writers have specific expertise in medicine, pharmacology, biology and statistics, and guarantee the utmost precision in the use of associated terminology. They combine writing skills with the ability to structure content according to precise guidelines which reflect both international best practices and the needs of readers – whether patients, the general public, doctors or regulators. Supported by mother tongue translators, revisers and editors, regulatory experts, and always on the basis of official and up-to-date sources, they also localize bibliographical and pharmacological reference texts in accordance with the law in the target countries.

Our teams can supply a completely personalized and scalable service on the basis of the specific needs of the client, seamlessly fitting in with the company’s processes and systems and with complete respect for ethical and industry standards.

The client provides documents, product descriptions and clinical cases, and our medical writers choose the most suitable form for the text which, depending on the ultimate goal, may be informational or promotional.

Furthermore, a team of doctors with various specializations, biologists and pharmacologists work in synergy with Landoor’s communication experts and editors to perform highly specialized activities, such as:

  • Localization of pharmaceuticals – to adapt aspects like the drug name, dosage and retail price of drugs in foreign countries to the market and regulations in the various countries, with a specific focus on non-EU countries (the US, first and foremost);
  • Editing and adapting bibliographies in accordance with Italian Legislative Decree 2019/2006 on drug safety for the referencing of pharmaceutical promotional material;
  • Checking that texts fully comply with legislation and directives, guidelines and regulations.

These services are mainly used by the pharmaceutical industry but can also be extended to medical products, cosmetics, wellness solutions and scientific translations.

Medical writing for regulations and pharmacovigilance

We are able to manage the entire life cycle of the wide array of regulatory documentation to present to the competent regulatory authorities, including:

  • Reports on clinical trials
  • Clinical trial protocols
  • Investigator brochures
  • Patient accounts
  • Clinical evaluation reports (CER)
  • Electronic Common Technical Documents (clinical and preclinical)

The communication of safety data is an integral part of a product’s regulatory documentation.  We have long experience in supplying a wide range of pharmacovigilance documents, such as:

  • Development safety update reports (DSUR)
  • Data safety monitoring board manuals
  • Periodic benefit risk evaluation reports (PBRER)
  • Periodic safety update reports

Medical communication services

We support clients that want to achieve their product launch goals through the strategic planning of publications and the development of an extensive series of medical communication documents, including:

  • Manuscripts (clinical trials, meta-analyses, reviews, surveillance studies)
  • Proceedings and minutes of consultation bodies
  • Articles for scientific magazines
  • Abstracts
  • Research and reviews of medical and scientific literature
  • Summaries of product characteristics
  • Package inserts
  • Monographs
  • White papers
  • Articles, summaries and transcriptions of conference speeches
  • Digital content (copy for websites, blogs, newsletters, press releases)
  • Posters
  • Packets of slides

Content for facilitating access to markets

Understanding the economic advantages of the product in question and communicating them to sponsors and stakeholders is key to the success of a market access campaign. Our teams have extensive experience in the drafting of a wide range of health economics and pharmacoeconomics documents, including:

  • Texts on health economics and outcomes research (HEOR)
  • Evidence generation
  • Research and reviews of medical and scientific literature
  • HTA reports
  • Gap analyses
  • Protocols, reports, manuscripts
  • Posters, abstracts
  • Packets of slides
  • Rapid response forms

Health marketing texts

Our copywriters and transcreators strengthen the communicative power of scientific marketing content, press releases and reports for institutions.

We have the necessary expertise to convey the messages via various sales and marketing media, including:

  • Brochures
  • Medical handbooks and manuals
  • Leaflets
  • Billboards
  • Books
  • Digital content

Rigorous quality control

The documentation is delivered to the client in its final form following editorial checks and proofreading that guarantee the utmost precision of the texts in terms of both scientific content and linguistic accuracy. All aspects of every document undergo an exacting quality control process. We offer checks on all your documents using our checklists and standard operating procedures (SOP) but, on request, we guarantee respect for the client’s guidelines as regards:

  • Editing, proofreading, formatting, etc.
  • Cross-referencing of numbers, tables and figures in the text with the original data
  • Cross-referencing with citations and reference sources

Upon request, the copy created by the medical writers can be translated by the Landoor team into any major language and formatted using the most appropriate software.

Landoor’s editorial services and the technical/language services described above meet the requirements for ISO 9001:2008 certified procedures.

Please contact eliana.Tosoni@landoor.com for more information.

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