FAQ

Is The University of Iowa Pharmaceuticals (UIP) able to produce materials according to and meeting EMA (EU) standards?

 

Is UIP able to safely handle potent/cytotoxic materials?

 

Does UIP have a cleaning verification program in place?

 

Does UIP have the expertise to develop formulations?

 

Has UIP worked with foreign companies?

 

Who from UIP serves as the primary interface with the client organization?

 

Is UIP able to work with controlled substances?

 

How do business relationships with UIP work?

FAQ

Is The University of Iowa Pharmaceuticals (UIP) able to produce materials according to and meeting EMA (EU) standards?

Yes.  UIP has produced numerous products which have been used in European clinical trials and subject to QP review.

 

Is UIP able to safely handle potent/cytotoxic materials?

Yes.  UIP has been safely handling potent/cytotoxic materials for over 20 years.

 

Does UIP have a cleaning verification program in place?

Yes.  After the manufacture of products containing an active ingredient that utilizes non-dedicated equipment, cleaning swabs are collected and assayed for residual drug substance and detergent.

 

Does UIP have the expertise to develop formulations?

Yes.  UIP has been developing formulations for oral, topical, and parenteral dosage forms for over 30 years.

 

Has UIP worked with foreign companies?

Yes.  UIP has worked with companies from all over the world including South Korea, Japan, Germany, Finland, Ireland, and Canada.

 

Who from UIP serves as the primary interface with the client organization?

For manufacturing projects the primary interface starts with the manufacturing departmental manager and as the product comes closer to being manufactured the interface responsibility is transferred to the actual manufacturing project leader.  For analytical aspects of projects the primary interface is with the laboratory manager.

 

Is UIP able to work with controlled substances?

Yes.  UIP is licensed to work with Schedule I – V controlled substances and is in full compliance with DEA regulations.  UIP has been licensed to handle controlled substances for over 20 years.

 

How do business relationships with UIP work?

The initial stage to most projects is the establishment of a CDA and/or Master Services Agreement.  Once these are in place a project questionnaire is completed detailing the project and a quote is provided.  Once the quote is accepted and a work order provided, work begins on the project and a Quality Agreement is put in place.  This can occur very rapidly if the client has a well-defined project at the time of first contact.  Once a project has been initiated, subsequent manufacturing runs can be initiated in a short time frame because all that is required is a quote and work order.  Since most work that UIP performs is strictly fee for service, intellectual property rights are retained by client organizations.

 

 

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