Yes. UIP has produced numerous products which have been used in European clinical trials and subject to QP review.
Yes. UIP has been safely handling potent/cytotoxic materials for over 20 years.
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.
Yes. UIP has been developing formulations for oral, topical, and parenteral dosage forms for over 30 years.
Yes. UIP has worked with companies from all over the world including South Korea, Japan, Germany, Finland, Ireland, and Canada.
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.
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.
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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