Areas of Expertise

Analytical Methods:  Lifecycle Approach

Adapting QbD principles to analytical methods, a Lifecycle Approach starts with identifying the right testing for a product then building the Analytical Target Profile to succinctly describe the expectations for the method.  This approach is used to drive method development, with subsequent validation, verification and transfer exercises designed to demonstrate that the method is suitable for its intended purpose.

Dissolution Methods

Assist with the development of dissolution methods for a variety of purposes, including formulation selection, routine Quality Control testing, comparability testing during scale up or production changes and pursuit of an IVIVC.  Facilitate troubleshooting and investigation of unexpected results.  Provide advice regarding dissolution instrument qualification.

Control of Impurities

Impurities may be drug related, such as process impurities and degradants, or general impurities, such as residual solvents or elemental impurities.

Provide recommendations regarding chromatographic characterization of potential drug related impurities using available information and forced degradation studies, understanding of ICH requirements for reporting, identifying and qualifying impurities and practical suggestions for incorporation into routine testing.

Provide latest available information regarding requirements for testing of general impurities, including residual solvents and elemental impurities, and practical strategies to minimize the overall resources requires to assure compliance with the requirements.

Out of Specification Investigations

Provide insight into the guidances regarding OOS investigations, including application to other investigations such as Out of Trend or Unexpected/Aberrant Data.  Provide training on Root Cause Analysis and appropriate Corrective and Preventive Actions as part of an overall strategy to minimize effort associated with investigations and to minimize recurrence.

Laboratory Audits and Proactive ‘Bullet-proofing’ in Preparation for Inspections

Use a Quality Systems Approach to perform laboratory audits, addressing all the major systems in a laboratory.  Will work with laboratory management to address deficiencies and improve both compliance and efficiency.   Utilize a systematic approach, based on years of industrial experience, to prepare laboratories for successful regulatory inspections.

Getting the Most Out of the USP

Help firms to understand how the USP works, how to anticipate upcoming changes and how to influence changes in the USP.

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