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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
June 30, 2020
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
November 02, 2017
Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
September 01, 2017
Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
March 02, 2017
A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.
Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.
February 01, 2017
More life-sciences companies are starting to manage global suppliers holistically.
November 28, 2016
Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor
August 01, 2016
Quality, innovation, and new approval pathways open drug development options for the Chinese market, including injectable contract manufacturing.
Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home. Compliance consultant John Avellanet shares best practices and ways to minimize costs.
May 02, 2016
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.