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EU Commission Concept Paper on API imports

Tuesday the 17th January 2012

Dear All,

The European Commission published a further Concept Paper regarding the implementation of Directive 20011/62/EU in December 2012. This Concept Paper was published to initiate public consultation regarding the implementation of the requirements for importing APIs from outside of the E...

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Quality Certification Program by Neil Wilkinson

Friday the 13th January 2012

The Pharmaceutical Industry continues to go through an unprecedented rate of change, driven by socio-economic, fiscal and globalization factors. This level of change is here to stay for the foreseeable future. For many of us these are challenging times, with mergers, acquisitions, plant closures...

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How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 1

Monday the 9th January 2012

by Peter H. Calcott, NSF-DBA Consultant

Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. B...

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How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 1

Thursday the 5th January 2012

Peter Calcott writes:
Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. But many people in th...

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NSF-DBA is recruiting a new Partner for Europe and UK office

Tuesday the 3rd January 2012

Due to increased business opportunities, we are recruiting an additional UK Partner to strengthen our established team, to be based in our Kirkbymoorside office. We are particularly, but not exclusively, interested in candidates with experience in clinical trials manufacturing and supply and/or ...

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Quick links

NSF-DBA have offices in Kirkbymoorside UK, Boston and Ann Arbor USA and South Africa

A word from NSF-DBA

At NSF-DBA we are committed to improving the competitive edge of your business by improving your regulatory compliance, streamlining your Quality Systems and maximising the contribution of your people through class-leading training.

Bob Pietrowski

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© NSF-DBA 2012

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