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Noble Writing & Consultancy | Providing a high quality regulatory medical writing and formatting service

Noble Writing & Consultancy provides a high quality service; authoring submission ready regulatory sections (eg. IBs, module 2 written and tabulated eCTD sections for INDs, NDAs, MAAs ), study reports and QC. Also, updating old regulatory dossiers to current eCTD standards and formatting study reports (PDF bookmarking, hyperlinking etc).

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CONTACTS AT NOBLEWRITING.COM

NOBLE WRITING & CONSULTANCY LTD

GILLIAN ALLAN

1 GR●●●● WAY

BROA●●●●ARIS , CT10 2YP

UNITED KINGDOM

4401●●●●1128
4407●●●●7431
GI●●●●●●●●@NOBLEWRITING.COM

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NOBLE WRITING & CONSULTANCY LTD

GILLIAN ALLAN

1 GR●●●● WAY

BROA●●●●ARIS , CT10 2YP

UNITED KINGDOM

4401●●●●1128
4407●●●●7431
GI●●●●●●●●@NOBLEWRITING.COM

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Noble Writing & Consultancy | Providing a high quality regulatory medical writing and formatting service | noblewriting.com Reviews
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DESCRIPTION
Noble Writing & Consultancy provides a high quality service; authoring submission ready regulatory sections (eg. IBs, module 2 written and tabulated eCTD sections for INDs, NDAs, MAAs ), study reports and QC. Also, updating old regulatory dossiers to current eCTD standards and formatting study reports (PDF bookmarking, hyperlinking etc).
<META>
KEYWORDS
1 Gill Allan
2 DMPK specialist
3 DMPK consultant
4 regulatory medical writing
5 DMPK
6 regulatory submissions
7 Module 2
8 investigators brochure
9 IB
10 eCTDs
CONTENT
Page content here
KEYWORDS ON
PAGE
services,about us,useful links,regulatory submission documentation,study reports,and css,link to linkedin
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iso-8859-1
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Noble Writing & Consultancy | Providing a high quality regulatory medical writing and formatting service | noblewriting.com Reviews

https://noblewriting.com

Noble Writing & Consultancy provides a high quality service; authoring submission ready regulatory sections (eg. IBs, module 2 written and tabulated eCTD sections for INDs, NDAs, MAAs ), study reports and QC. Also, updating old regulatory dossiers to current eCTD standards and formatting study reports (PDF bookmarking, hyperlinking etc).

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Noble Writing & Consultancy | Providing a high quality regulatory medical writing and formatting service

http://www.noblewriting.com/index.html

Formatting and/or QC of existing regulatory submission documentation, project management, DMPK (drug metabolism and pharmacokinetics) background. Authoring, submission ready formatting and QC of non-clinical and clinical study reports and patient/ safety narratives. Formatting PDF study reports to comply with submission ready regulatory agency guidelines. Highly organised professionals with excellent project management skills, who will deliver outstanding documentation to meet the agreed timelines.".

2

Services | Regulatory Submission Documentation, Study Reports, Formatting and QC

http://www.noblewriting.com/regulatory.html

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. Preparation of eCTD module 2 nonclinical tabulated summaries. Authoring initial or updates to investigators brochure for Clinical Trial Application (CTA), IMPD or eCTD submissions. Reformatting old style submission documents to current eCTD format.

3

Useful Links | ICH, EMA, FDA, EMWA, DMDG

http://www.noblewriting.com/useful-links.html

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). European Medicines Agency (EMA) - Health Medicines. US Food and Drug Administration (FDA). European Medical Writers Association:. Drug Metabolism Discussion Group. 2012 Noble Writing and Consultancy Ltd html. UK Registered Company Number: 7566379 VAT registration Number: 112842736.

4

About | Gill Allan, Noble Writing & Consultancy

http://www.noblewriting.com/about-us.html

Director of Noble Writing and Consultancy Ltd. As a DMPK lead, built up knowledge of pharmacokinetics across species, including human PK predictions, PK/PD, biotransformation, drug disposition and the potential for drug-drug interactions. Http:/ uk.linkedin.com/pub/gill-allan/2a/8a9/51a. Formatting and/or QC of existing regulatory submission documentation, project management, DMPK (drug metabolism and pharmacokinetics) background. We partner with you every step of the way to help you make the right decis...

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Noble Writing & Consultancy | Providing a high quality regulatory medical writing and formatting service

Formatting and/or QC of existing regulatory submission documentation, project management, DMPK (drug metabolism and pharmacokinetics) background. Authoring, submission ready formatting and QC of non-clinical and clinical study reports and patient/ safety narratives. Formatting PDF study reports to comply with submission ready regulatory agency guidelines. Highly organised professionals with excellent project management skills, who will deliver outstanding documentation to meet the agreed timelines.".

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