Clare Kennedy, manager© Kennedy Writing ServiceSint-Dorotheastraat 12, 9040 Sint-Amandsberg, Belgium - +32 (0)472897289
In the dynamic and demanding world of pharmaceuticals it is vital and of utmost importance that medical texts are written in accordance with the latest Directives. They should be written in a clear, concise and succinct manner. KENNEDY WRITING SERVICE employs experienced, reliable Native English Personnel to guarantee high standards , optimal service and above all client satisfaction.
KENNEDY WRITING SERVICE is dedicated to providing its clients with perfectly written, high quality, comprehensive and convincing texts. KENNEDY WRITING SERVICE ensures that it is, at all times, informed of current developments, including the latest guidelines and regulatory requirements.
Clare Kennedy, manager© Kennedy Writing Service - Sint-Dorotheastraat 12, 9040 Sint-Amandsberg, Belgium - +32 (0)472897289
KENNEDY WRITING SERVICE guarantees the delivery of PSURs, Modules 2.4 (and Modules 4.3), Modules 2.5 (and Modules 5.4) that are:
- Fully compliant with ICH and GCP guidelines- Written in a concise, accurate and succinct manner- Perfectly written by native English speakers- Comprehensive- Convincing
KENNEDY WRITING SERVICE handles the writing of:
A Periodic Safety Update Report is a report presenting the worldwide safety experience of a medicinal product at defined times post-authorisation.
Once a medicinal product is authorised in the EU, even it is not marketed, the MAH (Marketing Authorisation Holder) is required to submit a PSUR. PSURs are normally required to be prepared at 6-month intervals for the first two years following the medicinal product’s authorisation in the EU, annually for two years, at the first renewal, and then 5-yearly at renewal thereafter.
The Nonclinical Overview presents an integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicological evaluation of the medicinal product concerned. Overview presents an integrated and critical assessment of the pharmacologic, pharmacokinetic, and the pharmaceutical.
The Clinical Overview provides a critical analysis of the clinical data.
KENNEDY WRITING SERVICE can also perform bibliographic searches upon request
KENNEDY WRITING SERVICE believes in the importance of excellent communication through the power of the written word and is dedicated to providing proofreading and editing services which deliver clear, fluent and lucid texts tailored to individual requirements. KENNEDY WRITING SERVICE ensures that spelling, grammar and punctuation are accurate as well as ensuring that the construction, style and flow of your work is flawless, fault free and of excellent quality.
KENNEDY WRITING SERVICE can proofread, correct, edit and perfect ANY type of English document. As translations to English are sometimes not carried out by Native English Speakers there is a necessity to double-check documents. After all the final document represents the client. Therefore texts should be perfect in order for clients to exude an excellent and highly professional image.