
Regulatory Document Experts
From concept to label, let our medical writers at Red Thread Consulting help you weave the evidence-based messaging

From concept to label, let our medical writers at Red Thread Consulting help you weave the evidence-based messaging

Our mission is to deliver expert guidance and support in the development of regulatory documents, ensuring clear and effective communication of the messages for your drug product during dossier creation and throughout the product lifecycle.

Our experienced team can provide range of services, including writing, consulting and governance and oversight.
We can take responsibility for a document from the start or its journey until completion. Our aim is to get it right the first time and in the shortest possible time, thereby reducing the number of inquiries you receive from agencies.

Red Thread Consulting adopts a collaborative consulting approach. We engage closely with our clients to understand their requirements and craft solutions that address their distinct challenges. Our methodology is characterized by transparency, a focus on results, and a commitment to facilitating business success.
Our expertise in regulatory submissions and agency responses spans the globe, encompassing the regions indicated on the map, as well as successful submissions to the World Health Organization (WHO).
Katharine and her team provide exceptional regulatory and medical writing support throughout clinical trial documentation development processes. From protocol outlines to detailed correspondence with regulatory authorities, Katharine consistently delivers high quality work under tight timelines, leading cross-functional teams with agility and efficiency. I highly recommend Katharine and Red Thread Consulting’s services to any organisation in need of top-tier regulatory and medical writing support.
Having worked in regulatory for over 25 years including leadership roles in industry and consulting environments, I truly value and appreciate the experience, expertise, and absolute dedication that Katharine and her team provide. Not only has Katharine supported NDAs/BLAs/MAAs (including response to questions), CTA/INDs, scientific advice, orphan applications and other briefing books, she always brings invaluable insights into executional strategy, is always professional, is always on-time and on agreed budget. I have learned a lot! I am certainly looking forward to the next decade of working together.
I have worked with Katharine several times over the years on various medical writing projects, including Clinical Study Reports and entry into clinicaltrials.gov. She has a keen sense of the complexity of our oncology trials, and is able to work seamlessly with our team to provide top-notch reports. Katharine is always ready to meet with our team to provide thoughtful input on each project, and her projects are completed on time and on budget. I would highly recommend Katharine and Red Thread Consulting for any medical writing needs.
