Noble Writing & Consultancy Ltd
Business Coaches
Noble Writing & Consultancy Ltd
1 Grange Way, Broadstairs
# Noble Writing & Consultancy Ltd
Noble Writing & Consultancy Ltd is a specialist medical writing and regulatory consultancy based in Broadstairs, serving pharmaceutical companies, biotech firms and contract research organisations across the drug development lifecycle. Founded in 2011 by Gill Allan, the company brings together extensive expertise in non-clinical and clinical regulatory documentation.
The business specialises in preparing comprehensive submission documentation required for regulatory approval across multiple regions. This includes authoring eCTD Module 2 written summaries for INDs, NDAs, MAAs and BLAs, alongside clinical study reports, non-clinical summaries and investigators' brochures. Their work spans diverse therapeutic areas including oncology, infectious diseases, respiratory, pain management and biologics development.
What distinguishes Noble Writing & Consultancy is Gill's 13 years' prior experience within a DMPK department at a leading pharmaceutical company, combined with over a decade of independent consultancy. This background enables a deep understanding of drug development complexities and global regulatory requirements. The team adopts a flexible, tailored approach to each client's needs rather than applying generic solutions.
Beyond document authoring, they provide valuable project management services—chairing kick-off meetings, coordinating multidisciplinary teams and ensuring quality control. Their ability to reformat legacy documents to current eCTD standards and produce submission-ready PDFs with professional bookmarking and hyperlinking demonstrates practical efficiency.
The company positions itself as a strategic partner throughout the regulatory process, combining meticulous attention to detail with streamlined project delivery to meet demanding timelines.
Noble Writing & Consultancy Ltd is a specialist medical writing and regulatory consultancy based in Broadstairs, serving pharmaceutical companies, biotech firms and contract research organisations across the drug development lifecycle. Founded in 2011 by Gill Allan, the company brings together extensive expertise in non-clinical and clinical regulatory documentation.
The business specialises in preparing comprehensive submission documentation required for regulatory approval across multiple regions. This includes authoring eCTD Module 2 written summaries for INDs, NDAs, MAAs and BLAs, alongside clinical study reports, non-clinical summaries and investigators' brochures. Their work spans diverse therapeutic areas including oncology, infectious diseases, respiratory, pain management and biologics development.
What distinguishes Noble Writing & Consultancy is Gill's 13 years' prior experience within a DMPK department at a leading pharmaceutical company, combined with over a decade of independent consultancy. This background enables a deep understanding of drug development complexities and global regulatory requirements. The team adopts a flexible, tailored approach to each client's needs rather than applying generic solutions.
Beyond document authoring, they provide valuable project management services—chairing kick-off meetings, coordinating multidisciplinary teams and ensuring quality control. Their ability to reformat legacy documents to current eCTD standards and produce submission-ready PDFs with professional bookmarking and hyperlinking demonstrates practical efficiency.
The company positions itself as a strategic partner throughout the regulatory process, combining meticulous attention to detail with streamlined project delivery to meet demanding timelines.
Services offered
eCTD Module 2 written summariesNon-clinical study reportsClinical study reportsInvestigators' brochure authoringStudy report formatting for regulatory submissionProject management of regulatory compilationsQC and review of regulatory documentationeCTD reformatting and updates