On behalf of the team I must say it was a pleasure working with DBA on this project.

This is what their COO had to say when Terry Snape, Associate with David Begg Associates, helped a small start up company prepare their Quality System for Scale Up and Phase 1 Clinical Trials:

“I can only reply that my expectations from DBA have once again been completely met and then some.  I am looking forward to working with this team in the happy knowledge that, with your guidance and input, we will get this task completed.

“Gary and Jim,                   

I would like to inform you that we had a successful inspection from the MHRA.  We had 1 major observation and 7 others.  The inspector did mention that he will be back late 2010/early 2011 to inspect both the OSD and Parenteral operations once all of the necessary documents have been file with the appropriate agencies.  We would like to thank both of you again for your help in preparing this site for the inspection.  The inspection would not have been successful without your efforts.”

Our consultant, George Urwin, helped a UK company to prepare for an FDA inspection.  He received the following feedback after successful completion of the inspection ....

"Just to confirm we are very grateful to you for the help you gave us.  Everything you said (the FDA inspector) would do she did!  You really helped us a lot."

We received the following message from a company in the USA, who we had assisted with their preparation for an audit by the EMEA, after a very successful inspection by the German Inspectors from Schleswig Holstein where they received no Critical, no Major and only a few "Other" comments.

“Dear David,

I can confirm that the inspection ended last Thursday with an excellent result as you already know and I hope to get the inspection report with the ‘other’ observations soon.

I’d like to express that your support and the consultancy by David Begg Associates was an essential element in achieving this result. In fact, considerable improvements at < > were recognised, all observations of the last inspection were sufficiently corrected and last but not least the inspectors were treated in a respectful and professional way.

 David, in particular I’d like to thank you for our cooperation and I enjoyed working with you.”

Our consultant Gary Rees carried out a mock EU inspection for one of our US clients.  Here is the feedback we received...

"Hi Gary,
Well done!  This is one of the best, if not the best preparation audit I have been involved with.
Senior Director, Operations"

Halfway through a mock regulatory audit conducted by Liz Allanson and Stewart Green, we received the following comments from the client...

"Just wanted to send a note to tell you how impressed I am with Stewart and Liz.  The site here has been very complimentary on their approach and style.  They are giving them a run for their money, which I wanted."

Following an adverse EU regulatory inspection of its operations, the company retained a US consultancy to assist with their response.  The approach adopted was based on a typical response to FDA, responding to individual observations without addressing underlying systematic failings.  This approach sadly made the situation worse.  At this point the company approached DBA for assistance.  With our help, the company embarked on an intensive programe to re-shape its quality management system plus focussed training for staff at all levels.  The company passed the follow-up inspection with flying colours.  DBA's involvement was viewed as 'pivotal' by the company.  EU regulators reviewed the training provided by us and commented, "This is what we have learnt to expect from DBA."