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News and Press Releases

Signant Health Launches Partner Program to Team with Clinical Research Organizations (CROs) Committed to Improving Clinical Trials with Patient-Centric Technology

PHILADELPHIA August 12, 2019: Signant Health (signanthealth.com), a leading provider of technology for clinical research, today launches the Signant Health Partner Program, a significant investment the company is making to enable clinical research organizations (CROs) to better serve sponsors in the areas of Patient Data, Patient Experience, Clinical Supplies, and Endpoint Quality Solutions. By becoming a Signant Partner, CROs will benefit from new commercial and operational advantages that only come with membership.
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White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India forhigh quality, low   cost pharma solutions, CPhI & P-MEC Indiais the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from Indias pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
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