Specialist Medical Writing Solutions for You From protocols and informed consent forms to clinical study reports to new drug applications - taking a new medicine or medical device requires writing and submitting hundreds of thousands of pages of documentation from concept to market. These documents and reports must be written accurately, efficiently and without errors while maintaining full regulatory compliance to minimize time to market.
Providing complete, end-to-end communications services needed throughout each critical stage of development and commercialization, our newly enhanced and fully-integrated Medical Writing Company delivers the unique expertise to communicate with a wide range of audiences. To provide customers the added value that come with continuity and streamlined communications throughout the life cycle - our consolidated medical writing services build upon our already-available scientific, technical, medical, regulatory and commercialization communications services. By supporting preparation of a wide range of clinical regulatory documents, our team of PhD and Master’s level writers with diverse therapeutic backgrounds help us to achieve our goals fluently:
Clinical Protocols, Clinical Study Reports, patient narratives Integrated analysis of effectiveness and safety INDs, IMPDs and annual reports Product circulars, summary of product characteristics Agency background packages Investigator Brochures Pharmacovigilance documents Manuscripts, abstracts, posters and presentations Literature reviews CTD summaries Quality control checks before document submission
Single point of contact A medical writer is responsible for managing the writing process for each project here at our Medical Writing Company. To ensure you are aware of progress against timelines, a communication plan is drawn up at the beginning. Our rigorous quality assurance process ensures all regulatory requirements are met and that you are provided with a professional, efficient service. At the request of clients, we also offer certified translations of all medical writing services for our projects. Our customized flexible Outsourcing Solutions We understand your need to select a model that aligns with your own medical writing approach and needs. As a leading Medical Writing Company, we help select the services you need and the flexible contract model that fits your company, your project, and your budget by working with you throughout. We will ensure that you have access to our extensive global reach, broad therapeutic expertise, product development knowledge, process know-how, and the high quality that you would expect from one of the world’s leading bio pharmaceutical service companies, no matter whether it is part of full clinical study, a standalone project or a functional service project.