Gaseous Sterilization – New USP General Chapter


Inspection Management – How to Pass EU and FDA Inspections

A Second Look – The Best GMP Contracts

Oh, By The Way...

There are firms that promote various Guaranteed Maximum Price (GMP) contracts. Why?

In order to have a true GMP contract one needs to develop the design, issue the documents for bidding and then having the work performed without any or a minimal amount of change orders.  This concept sounds a lot like the traditional design, bid and build construction – which is the most cost effective method to deliver a project.

On GMP contracts it is not unheard of for the project costs to balloon way past the estimated project costs.  Why does this happen?  Because the design requirements were not finalized prior to issuing the documents and the most costly time to fix design or construction problems is during the construction period.

Changes to the scope during construction will create cost increases and delays that must be compensated for during the construction period.  While owners and developers maybe hoping…

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Renewal of Marketing Authorizations in EU – Regulatory Week

May 9, 2013 | By Márcio Barra


It’s the fourth day of regulatory week! This means a new regulatory affairs themed short article! Today, how do Marketing Authorization’s renewals work in Europe. If you like this article, please share it!

Renewal of Marketing Authorizations in EU

Marketing authorizations in Europe are valid for five years from the date of notification of the Commission Decision to the marketing authorization holder, and may be renewed on the basis of a re-evaluation of the risk-benefit evaluation balance according to Regulation (EC) 726/2004(1).The application for renewal of a MA must be sent to the appropriate competent authority at least 9 months before the expiration date(1).

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