Victoria graduated from university with a BSc in Chemistry with analytical science and began working as a quality control operative for ProSynth Ltd. In 2006 Victoria commenced a new role at Mundipharma Research Limited in the analytical team within Product Development. In this role Victoria gained extensive experience of drug development along with skills in project management and generation of regulatory documentation for clinical trials (Phase I-III) and Module 3. In 2017 Victoria moved to the Regulatory CMC team within Mundipharma Research to a role that involved authoring, review and submission of Module 3 MAA/NDA for Europe, APAC and LATAM and associated query response activities. Victoria also gained significant experience leading submissions for post approval changes in Europe, APAC and LATAM. In 2019 Victoria joined Kinapse as a Senior Manager in Regulatory CMC supporting multiple clients in both pre and post approval activities. Victoria rejoined Mundipharma in 2021 as the Head of Regulatory CMC and in this role and is responsible for the team providing regulatory CMC strategy across all the portfolios to maintain global compliance and support commercial opportunities.
In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to ...
Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.
The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals
A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.