Our help with medical writing should enable you to present your clinical and regulatory documentation in the best possible way. You can optimise your communication of your results from research, trials, or development to journals, authorities, or the audience of your choice.
The growing demand for clearly articulated medical science drives the demand for well-written, standards-compliant documents that medical professionals can easily and quickly read and understand.
A medical writer is highly useful throughout the development process, doing the following:
Producing documents that effectively and clearly describe research results, product use, and other medical information.
Ensuring that the documents comply with regulatory, journal or other guidelines in terms of content, format, and structure.
Accounting for the purpose of the document and what the health authority assessor needs to know about the program or study.
Taking the regulatory framework into account.
Perfecting the message, so that it is precise, clear and inclusive of the relevant amount of information to ensure that the reviewers can evaluate your product.
Our consultants are experts in handling and preparing regulatory documentation. We will work closely with your subject matter experts to make sure that the clinical and regulatory documentation matches the health authorities’ expectations and provides sufficient context where needed.
Clinical trials advice and submission documents
Scientific advice support
PIPs
Orphan product support
Erik Hedner
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
