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PharmAssist Analytical Laboratory

The cornerstone philosophy of PharmAssist is that we are scientific partners with our customers in solving their analytical problems. This partnership philosophy means that we continue to support our clients beyond the analytical report. A scientifically critical approach is taken to all research, whether it is a single sample or a complex method development/validation performed in conjunction with a regulatory submission.

FDA registration number: 1319276

PharmAssist undergoes regular FDA inspections. Copies of these inspection results are provided to clients upon request. In addition, PharmAssist has been audited by a variety of pharmaceutical manufacturers, and encourages inspections from all of our clients. Customers will often request method transfer studies as part of the laboratory selection process. PharmAssist welcomes such studies, and performs them on a cost basis for our clients.

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Method Development and Validation PharmAssist engages in custom method development and validation for a range of pharmaceutical products at different stages of development with particular emphasis on chromatographic techniques.

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Stability Studies Stability studies are performed for active pharmaceuticals and finished dosage forms. Assistance can be provided with the design of stability protocols and methods.

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Release Testing PharmAssist is capable of handling substantial quantities of samples for release testing employing a variety of techniques.

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Method Development

PharmAssist engages in custom method development and validation for a range of pharmaceutical products.

A comprehensive method development and validation report is sent to the client upon completion of the studies. PharmAssist will help the client transfer the method to their own laboratory, by written protocols and telephone conversations with the appropriate personnel, and/or by on-site visits to the client's laboratory. PharmAssist can also serve as an outside laboratory to critically evaluate new methods developed by the client, prior to their implementation. This provides additional ruggedness data, and helps to unmask potential problems with the method before problems occur in the QC lab.

Stability Studies

Stability studies are performed for active pharmaceuticals and finished dosage forms.

Assistance can be provided with the design of stability protocols and methods. PharmAssist can store the samples on site and maintain the calendar pull dates. Additional chambers for accelerated and real-time conditions are added to meet customer demands. For clients who generate their own stability samples, we offer analyses using the provided methods. Turnaround time is set by the customer, typically 1-2 weeks. We realize that there is rarely a "routine" analysis involved in stability work; our scientific depth and corporate philosophy enable us to detect potential problems and to provide effective solutions in a timely manner.

Release Testing

PharmAssist is capable of handling substantial quantities of samples for release testing employing a variety of techniques.

Testing techniques include HPLC, Mass Spectrometry, Dissolution (Apparatus 1 and 2, Rotating Bottle), Disintegration, GC, CE, UV-Vis and various wet chemical methods. Release samples are automatically assigned a priority status; work is typically begun on the day of receipt, with no surcharge to the customer. Post-analysis consultation by the client with the senior supervisory staff of PharmAssist is encouraged should a question arise regarding any aspect of the analysis.

PharmAssist maintains written standard operating procedures for all aspects of the laboratory operation, in compliance with cGMP guidelines and generally accepted industry standards.

Key Personnel

Kathleen Stith President

Richard Hartwick, Ph.D. Chief Scientific Officer

Kathleen Stith is President, and has over 25 years of experience in the pharmaceutical industry in both analytical development and regulatory submissions. Richard Hartwick, Ph.D., is the Chief Scientific Officer. Formerly, an analytical professor at both Rutgers University and SUNY at Binghamton , he has 30 years experience in developing separations for pharmaceutical and biomedical analyses, and in basic scientific research in HPLC, GC and Capillary Electrophoreses. He has served as a consultant for a variety of pharmaceutical companies, and has published over 120 research articles and books on various aspects of chromatographic theory and analysis.

Our laboratory staff is highly trained, with analysts holding a B.S. degree or higher. Professional development is maintained through various short courses and by attendance and submissions at key scientific and professional society meetings