University of Iowa Pharmaceuticals provided services meet both FDA and EMA quality standards. The quality of all products is assured.

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Lyophilization Cycle Development

 

Clinical Supply Manufacturing

 

Small Scale Commercial Manufacturing

 

Analytical Method Development and Validation

 

Routine Quality Control Analysis

 

Stability Assessment

 

Formulation Development

 

Comparator Products

 

Powder in a Bottle

 

Preformulation Studies

 

Active Pharmaceutical Ingredient (API) and Excipient Release Testing

 

QP Release Services

 

QP Release Services

The University of Iowa Pharmaceuticals (UIP) has a QP available to sponsors wishing to obtain QP release for their products for clinical trials in the European Union.  Our QP is Russell Thomson, Managing Director and Principal Consultant of TPQ Consultancy, Ltd in the United Kingdom.

 

Picture of Russell Thomson

Along with his QP certification, Russell has extensive experience across the full range of CMC related activities associated with the development, manufacturing (both clinical and commercial), and registration (from API synthesis to finished product packaging) of a wide range of dosage forms focused in the EU regulatory space.

 

Russell has visited our facility on numerous occasions to conduct QP audits and has provided UIP a GMP Audit Certificate confirming his assessment of the general compliance of the operations and systems of UIP with the requirements, principles, and guidelines of European Commission Directive 2003/94/EC as interpreted in EudraLex – Volume 4 Good Manufacturing Practice (GMP) Guidelines.

 

Russell’s availability will lower your QP release services cost and save you time. Additionally, he can provide links to European service providers who can be utilized for product importation. If his recommended CMO is used for product importation, he can provide a QP Declaration for supplies intended for utilization in European clinical trials.

 

If you have any questions regarding our QP Certification details, please Contact Us.