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SYLEXIS.CO.UK

Sylexis - consultancy and writing services for the pharmaceutical, biotechnology and medical devices industry

Sylexis Limited - Consultancy and writing services for the pharmaceutical, biotechnology and medical devices industry.

http://sylexis.co.uk/

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Sylexis - consultancy and writing services for the pharmaceutical, biotechnology and medical devices industry | sylexis.co.uk Reviews
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Sylexis Limited - Consultancy and writing services for the pharmaceutical, biotechnology and medical devices industry.
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1 medical writing services
2 experienced clinical writers
3 report writing
4 consultants
5 pharmaceutical reports and documentation
6 medical writers association
7 market assessments
8 product development planning
9 ethics & regulatory submission document preparation
10 clinical trials
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Sylexis - consultancy and writing services for the pharmaceutical, biotechnology and medical devices industry | sylexis.co.uk Reviews

https://sylexis.co.uk

Sylexis Limited - Consultancy and writing services for the pharmaceutical, biotechnology and medical devices industry.

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sylexis.co.uk sylexis.co.uk
1

Sylexis - Regulatory writing services for thepharmaceutical and medical devices industry

http://sylexis.co.uk/about_gillian.htm

Sylexis Limited is managed by Dr Gillian Pritchard, an experienced pharmaceutical physician and regulatory writer with expertise in early and late phase product development in Europe and the USA, to ICH-GCP standards, across several therapeutic areas, e.g. clinical pharmacology, diabetes and cardiovascular medicine, within academia, pharmaceutical, contract research and medical devices consultancy companies. Regulatory writing services for the pharmaceutical and medical devices industry.

2

Sylexis - Regulatory writing services for thepharmaceutical and medical devices industry

http://sylexis.co.uk/index.htm

Was established in 2006 and offers regulatory writing services to the pharmaceutical and medical devices industry. Examples of work undertaken include:. To support initial CE marking or CE renewal in accordance with the MDD. For research planning and CE marking of medical devices. Common Technical Document (CTD):. Clinical Overviews (2.5) and Summaries (2.7). Reports written and Appendices compiled to ICH-E3 standards. Writing safety narratives for clinical study reports.

3

Sylexis - Regulatory writing services for thepharmaceutical and medical devices industry

http://sylexis.co.uk/work.htm

Examples of completed projects include:. Including literature reviews for the following indications:. General surgery e.g. inguinal hernia repair, wound closure materials. Peripheral vascular stents and guidewires. Cardiology devices e.g. for septal defects, mitral valves. Orthopaedic implants e.g. spine fixation. Updating a premarket application (PMA). For a bariatric device. Clinical Overviews and Summaries:. Phototesting of sunscreen products. Treatment of P. falciparum. Malaria in adults and children.

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consolida.com consolida.com

Consolida market assessment, regulatory strategy and commercialisation consultancy for the biomedical and life sciences sector

http://www.consolida.com/people.html

Consolida market assessment, regulatory strategy and commercialisation consultancy for the biomedical and life sciences sector. Gill Howcroft is Director of Consolida. Gill has 13 years experience of medical product development:. 1 year as Director of Consolida Limited;. 4 years: Research and Commercialisation Manager, with a Scottish bio-medical consultancy company (Pleiad Limited);. 2 years as a clinical trial monitor in Contract Research Organisations (Innovex, PharmaPart);.

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Sylexis - consultancy and writing services for the pharmaceutical, biotechnology and medical devices industry

Offers the following services to the pharmaceutical, biotechnology and medical devices industry and to universities and research institutes:. Reports written to ICH-E3 standards. Writing safety narratives for clinical study reports. Common Technical Document (CTD):. Clinical Overviews (2.5) and Summaries (2.7). To support research planning and CE marking of medical devices. An experienced Research and Commercialisation Consultancy. Offered by Sylexis include preparation of:.

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