Comprehensive drug development experience enables us to provide a top-class service across a wide range of freelance medical writing assignments.
OUR SERVICES
A highly organised, efficient professional with excellent project management skills, who will deliver outstanding documentation to meet the agreed timelines.
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Our services offer a flexible approach, tailored to each and every client's specific needs.
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We partner with you every step of the way to help you make the right decision at the right time.
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REGULATORY SUBMISSION DOCUMENTATION
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Authoring electronic Common Technical Document (eCTD) Module 2 written summaries for Investigational New Drug (IND), New Drug Application (NDA), Marketing Authorisation Application (MAA), Biologics Licence Application (BLA) and other regional submissions
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Preparation of eCTD module 2 nonclinical tabulated summaries
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Authoring initial or updates to investigators brochure for Clinical Trial Application (CTA), IMPD or eCTD submissions
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Reformatting old style submission documents to current eCTD format
STUDY REPORTS
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Authoring non‑clinical and clinical study reports
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Production of study report outline templates suitable for regulatory submission based on local and corporate SOPs and regulatory agency guidelines
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Formatting PDF study reports suitable for regulatory submission (including bookmarking, hyper linking and addition of table of contents)
OTHER SERVICES
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Project managing the process of compiling or updating regulatory documents, including chairing kick-off and review meeting; ensuring that a fully integrated, quality document is produced
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QC and review of existing documentation including eCTD, Investigators Brochure and study reports
ABOUT US
Gill Allan, Director of Noble Writing & Consultancy Ltd
Prior to founding Noble Writing & Consultancy in 2011, Gill already had 13 years' experience in a DMPK (drug metabolism and pharmacokinetics) department from a leading pharmaceutical company. She is a specialist in global regulatory submissions across many therapeutic areas including allergy and respiratory, pain, infectious diseases (e.g., HIV, HCV), GI, GU, oncology, biologics (e.g., mAb, stem cells). Gill is an excellent highly efficient project manager with extensive experience as a non-clinical writer to produce quality, submission ready documentation. She has good knowledge of the whole drug discovery and development process, with experience working from initial idea, through to post marketing commitments and additional filings / indications. Gill has experience working with a wide range of companies from early start-ups, new to the drug development and regulatory process, through to small, medium and large multi-national corporations.
Gill has extensive experience authoring, reviewing and QC of regulatory submission documents e.g., Investigator's Brochures (initial and annual updates), INDs (module 2 including Nonclinical overview, Written Summaries and Tabulated Summaries), MAA, NDA, Paediatric investigation plan, study reports, pre-IND briefing documents etc. She has submission ready formatting experience along with the production of quality submission ready templates. She is an experienced user of a wide range of document management systems.
In her previous role as a DMPK lead she built up knowledge of pharmacokinetics across species, including human PK predictions, PK/PD, biotransformation, drug disposition and the potential for drug-drug interactions.
LET'S WORK TOGETHER
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1 Grange Way, Broadstairs, Kent, CT10 2YP, United Kingdom
Phone +44 (0)1843 265065
Mobile +44 (0)7930 717431