News

Overview

Resolution  is now entering its 4th year of operation.  Business has grown steadily and thanks are due to our friends and customers for their support over this time.  2007 was a very successful year, with many Site Audits, Report Reviews and Data Reviews being conducted throughout Europe and North America on behalf of European, American and Japanese clients.  Customer feedback has been excellent, and it is intended to include some details of this on the website in the near future.

AAPS Workshop on Current Topics in GLP Bioanalysis:  Assay Reproducibility for Incurred Samples - Implications of Crystal City Recommendations.  

In February 2008,  Resolution was represented by Dr Gerry McGuire at the above meeting in Washington, D.C., held to discuss issues arising from the 3rd Bioanalytical Workshop on Quantitative Bioanalytical Methods Validation and Implementation:  Best Practices for Chromatographic and Ligand Binding Assays (Washington, D.C., May 2007).  Gerry had also attended the 3rd Workshop and, in January 2000, the 2nd Workshop on Bioanalytical Methods Validation (A Revisit with a Decade of Progress), ensuring Resolution's knowledge and awareness in this critical area is in accordance with the thinking and expectations of regulatory bodies .  If your company requires any advice on Regulatory issues in relation to Bioanalysis, please call or e-mail using the Contact section of the website.

FDA Letters of 10 January 2007 to Sponsors of Approved and Pending Abbreviated New Drugs Applications.

Following a detailed review of a number of studies conducted at MDS Pharma Services' facilities in St Laurent and Blainville, in early 2007 the FDA took further action and wrote to Sponsors of any bioequivalence studies used in support of a pending or approved ANDA which involved sample analysis at either of these sites over the period January 2000 to December 2004 (see http://www.fda.gov/cder/news/pharmaco_studies/default.htm ).  The letters recommended 1 of 3 courses of action be taken within 6 months of the date of the letter.  These were:

1. Repeat the study
2. Re-assay the samples at another facility
3. Commission an audit of the data by a qualified and independent expert to verify the reported results*

Although the permitted 6 month period elapsed in 2007, at this time not all companies have completed these actions.  If your company received a letter and has yet to act, Dr Gerry McGuire is very experienced in the review and audit of analytical data and is qualified to fulfill the FDA's requirements for an independent, expert, scientific audit of the bioanalytical data should your organisation choose option 3 (*note:  this is distinct from a Quality Assurance GLP audit).    Please follow this link to our Analytical Data Review page for further details.

Alternatively, if your company wishes to audit any of your existing or potential CRO analytical labs to ensure that there are no concerns over technical competence, science or quality, Resolution has the experience to undertake this on your behalf.  Please follow this link to our Facility Inspections & Technical Audits page for further details.

Training.  

Training feedback has been excellent.  Please check courses available for any that may be of interest by following this link to our Training page.