Regulatory Writing
We are equipped to support end-to-end development of regulatory documents, from the initial development stages of medicines and devices through to authorisation and post-marketing. The Ambermed team has experience in all phases of development, a plethora of study types, an extensive list of therapeutic areas, and a diverse range of regulatory documents, including:
The Ambermed team can support you with your medical communications strategy, write abstracts, manuscripts, articles, blogs, and white papers, and create presentation decks. We can also provide literature searches and help you select the right journal to gain maximum impact.Â
Providing peer reviews of documents can be a very powerful, and often underestimated tool. Peer review not only improves the quality of a document and ensures a second set of experienced eyes have seen it but it can also be used as a training tool to develop team members. The Ambermed team has a wealth of experience and has performed countless peer reviews that invariably spot oversights and omissions in documents.
We can offer in-depth quality control (QC) reviews of documents to ensure they are of the highest possible standards. The Ambermed team has document-specific QC checklists that they follow rigorously, along with checking consistency, grammar, style, and formatting.
The Ambermed team is trained in the art of plain language writing and can apply these skills to any documents deemed necessary. We can write lay language summaries for protocols and clinical trial reports (CTRs) in accordance with guideline recommendations. We can also create lay language summaries of abstracts, manuscripts and any other documents you require.
We can offer publishing of protocols, IBs, IMPDs, and many more documents. In addition, the Ambermed team can collect and collate appendices for CTRs and create an eCTD package including all the document components.
Ambermed's Transparency & Disclosure (T&D) team are well-versed in EU-CTR requirements, company confidential information (CCI) and personal protected data (PPD), and have redacted many Part I and Part II packages for CTIS submissions. The T&D team can also work with medical writers, data managers, statistical programmers, and other associated parties to anonymise documents (e.g., clinical trial reports) in accordance with Policy 0070.
We have an experienced team here at Ambermed and there are a multitude of other documents and tasks they have worked on. If you require assistance with global value dossiers, monographs, sales aids, health economics outreach research (HEOR), or anything else, please get in touch to see how we can help you.
