Case Studies
OBJECTIVES
A mid-sized European company specialising in pharmaceuticals, biopharmaceuticals, OTC, and cosmetic products faced significant compliance challenges in its global auditing program. With operations spanning multiple countries and involving diverse business and licensing partners, the company required a rigorous, risk-based audit approach to meet regulatory demands.
OBJECTIVES
 For a medium-sized pharmaceutical client, the objective was to enhance the effectiveness and authority of the Qualified Person for Pharmacovigilance (QPPV) in influencing the performance of the Pharmacovigilance (PV) system. This involved ensuring that the QPPV’s role, influence, and autonomy were clearly defined and documented within the client’s internal procedures.
Objectives
A pharmaceutical company was nearing completion of a multi-site, multinational registration trial. They had outsourced clinical development and regulatory submission, while a core team of experts maintained oversight. To strengthen operations, they brought in industry experts to bolster their QA team.
Background
The client (a small-sized, UK based, pharmaceutical company) was developing a new product and was preparing to submit a Clinical Trial Authorization (CTA) application to the Medicine and Healthcare products Regulatory Agency (MHRA) ahead of initiating clinical trials.
Our client is a small biotechnology company with a pipeline of products in advanced clinical development stage. The product portfolio they intend to offer into commercialization is across multiple therapy areas. It is a very science-driven company with majority of the senior management team from background in sciences, medicine, and manufacturing.
The Challenge
The company was on a digital transformation drive to support an upcoming commercialization. 2 of their key products were on registration paths at different regulated markets. With the advent of technology in many areas across the GxP domain, they were building activities of validation and control around the new technology that was introduced. There seemed to be a challenge to understand how to handle this from a strategic perspective.
Quality By Design Technology Intervention
Our client is a medical device manufacturer in Europe with a product that will be getting into clinical development stage soon. Their product is designed to address some challenges within the respiratory disease space. Their products are inspired by the passion to provide life-changing experience for patients suffering chronically.
The challenge
The client was looking for a quality by design implementation before they go into the clinical development stage for their product; quality-control solution that builds quality into production processes rather than testing failures out. They needed a system to increase efficiency with real-time data analysis to help them move past the paper-based reporting system they had previously relied on.
Reducing Cost of Quality
The manufacturing world have multiple challenges including global competition, regulatory landscape changes, and increasing capital costs and operating costs. Use of advanced technology and following latest trends in manufacturing management help overcome some of these problems.
A mid-size pharmaceutical manufacturer based in Europe operates in multi-therapy pharmaceutical product space. Their core competencies are providing products of high quality across the region through the national health care systems.
