by Prakash Achaary | May 25, 2023 | Blog
The Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...
by Prakash Achaary | May 15, 2023 | Blog
ICH E6(R3), a significant development on the regulatory horizon, is a revision to the International Council for Harmonization’s guidelines for Good Clinical Practice and is slated for release in August 2023. As the healthcare industry continues to evolve,...
by Prakash Achaary | May 10, 2023 | Blog
When it comes to undergoing a GxP audit interview within the regulated GxP industry, it’s important to be well-prepared by understanding the objectives and scope. This is particularly true for clinical research audits, which involve assessing compliance with...
by Prakash Achaary | Apr 18, 2023 | News
LONDON (18 April 2023) – MMS Holdings, a data-focused contract research organization (CRO), has been named a Great Place to Work-Certified™ organization in the UK. This comes as the number of MMS colleagues based in the UK has doubled in just one year. “We are...
by Prakash Achaary | Apr 14, 2023 | Blog
Good Laboratory Practice (GLP) compliance is an important aspect of research and development, as it creates trust and transparency between stakeholders in the process. When inspections occur, it is important to have all the necessary preparations in order, so the...
