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Regulator-e Associates Ltd provides expert regulatory
support and training to the Pharmaceutical Industry.
Providing quality documentation is not enough for us at
Regulator-e Associates. Each client project is evaluated to ascertain the optimal
solution, this normally means taking into account scientific and technical progress
through due diligence exercises and in-depth research of the ever-changing
Pharmaceutical Industry.
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REGULATORY SUPPORT |
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Document Preparation: |
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MAA conversion to CTD format
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Marketing Authorisations - European/International -
Mutual Recognition, Centralised or National procedures
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Clinical Trial Applications (2001/20/EC ) - Clinical Trial Directive
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End of Trial Notifications
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Clinical Study Reports
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Periodic Safety Update Reports (PSUR)
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Variations (1084/2003/EC, 1085/2003/EC)
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Licence Renewals
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Labelling and Leaflet preparation
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Quality Overall Summaries
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Drug Master Files
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National, European and International guidelines and
updates
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Regulatory Training: |
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MAA conversion to CTD format
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Basic Introduction to Regulatory Affairs
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Understanding the European Market - Mutual Recognition
and Centralised Procedures
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Clinical Trial Application requirements in the EU
(2001/20/EC)
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Understanding the International Regulatory Environment
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Regulator-e Associates offers a multitude of tailor
made courses for the Pharmaceutical Industry, whether
you are a start-up company or a multi national, please
feel free to contact us with any regulatory support or
training issues you require. |
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