Regis is a premier custom small molecule manufacturer with excellent analytical support services. Regis’ analytical capabilities are now available to customers requiring standalone pharmaceutical services. Our Analytical Method Development team (AMD) consists of highly skilled analytical chemists talented in developing and validating phase appropriate methods. Let Regis help support your analytical requirements from pre-clinical R&D through clinical development, and into commercial manufacturing.

IMPURITY SERVICES

Impurity Services

Impurity levels need to be understood and controlled for the benefit of safely administering pharmaceutical products to humans. Impurities impact not only the safety of drugs, but also the development time if not addressed early during the scale up process. Learn about elemental impurities and the new ICH Q3D and USP <232> and <233> guidelines here.

Regis offers services for impurity isolation, impurity characterization (including genotoxic impurity identification), synthesis scale-up for reference standards, and qualification for cGMP reference standards.

Click here to learn more or email Andy Miles with Pharmaceutical Services (amiles@registech.com).

STABILITY STUDIES

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. Stability studies test those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and efficacy. The testing includes as appropriate, the physical and chemical attributes.
 
Click here to learn more about Regis' stability services or email Andy Miles with Pharmaceutical Services (amiles@registech.com).
Stability Studies

FORCED DEGRADATION

Regis offers forced degradation studies from its Analytical Method Development team.

Watch a technical seminar on forced degradation given by Paul Wrezel, Ph.D.

STRUCTURE ELUCIDATION

Regis offers structural elucidation by its Process Research team.

Watch the video to the left to learn more about the "Structure Elucidation of Impurities in Drug Substance by 2D NMR" from our Director of Research, Igor Likhotvorik, Ph.D.

ANALYTICAL DEVELOPMENT STRATEGIES

ANALYTICAL METHOD DEVELOPMENT RESOURCES

Click the video on the right to view this technical seminar given by Paul Wrezel, Ph.D. 

Click here to read a paper on the "System Suitability and Validation for Chiral Purity Assays of Drug Substances." In this paper written by three members of the Regis AMD and Quality Assurance teams, they detail the following:

Measurement of chiral purity is a necessary means of quality control for drug substances that exhibit chiral centers. This paper will describe a simple and practical approach to setting up system suitability and validation for chiral purity assays.
 

Have a specific need? Email Andy Miles with Pharmaceutical Services (amiles@registech.com) for more information on how we can help with your project.

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