PharmaLex

ERA Consulting specializes in providing consulting services to the biopharmaceutical industry, focusing on regulatory affairs and product development. The company offers strategic advice tailored to prescription biopharmaceutical products and biomarkers. In addition to regulatory guidance, ERA Consulting provides a range of services including documentation, agency interaction, due diligence, auditing, and post-approval support. By delivering these comprehensive services, ERA Consulting aims to enhance the efficiency and profitability of its clients in the biopharmaceutical sector.

BioStat Solutions, Inc. offers specialized statistical analysis and strategic consulting services primarily to the pharmaceutical and biotechnology sectors, as well as the U.S. government. Established in 2001 and based in Frederick, Maryland, the company emerged from the National Cancer Institute, where its leadership gained significant expertise. BioStat Solutions emphasizes a tailored approach known as Precision Statistics®, which aligns statistical analysis tools with clients' specific research needs and business objectives. This methodology enables a collaborative environment where experienced statisticians, geneticists, and epidemiologists provide relevant insights and assist in interpreting statistical findings. Unlike traditional Clinical Research Organizations, BioStat Solutions employs a flexible staffing model to ensure that the appropriate expertise is available for each project, allowing for rapid project initiation and efficient use of resources. The firm is committed to developing effective study designs and implementing suitable analytical methods, ensuring that clients can navigate complex challenges, including those related to novel data and regulatory requirements.

Regulis Consulting Limited is a pharmaceutical regulatory consulting firm that provides a range of services, including regulatory affairs consultancy, pharmacovigilance consultancy, risk management, and quality assurance. Founded in 2001, the company operates from its headquarters in Tring, United Kingdom, and maintains an additional office in Dublin, Ireland. Regulis specializes in the pharmaceutical, biopharmaceutical, medical device, and cosmetics sectors. As of mid-2020, it functions as a subsidiary of PharmaLex GmbH.

Arbour Group L.L.C. is a provider of regulatory compliance technology and services tailored for the global life sciences industry. Founded in 1997 and based in Oakbrook Terrace, Illinois, the company specializes in software validation, packaged compliance solutions, and software testing and auditing. Arbour Group assists over 250 clients worldwide in managing business risk by ensuring compliance with FDA and international regulations, as well as industry best practices. Its regulatory products include packaged validation protocols that facilitate compliance with essential Enterprise Resource Planning (ERP) solutions. The company’s expertise encompasses high-quality testing across data center, infrastructure, and application layers, providing clients in the pharmaceutical, biotechnology, and medical device sectors with the necessary tools and methodologies for effective compliance management. As of February 2020, Arbour Group operates as a subsidiary of PHARMALEX GMBH.

TRAC Services Limited is an independent consultancy specializing in pharmaceutical regulatory affairs. Founded in 2001 and headquartered in Redruth, United Kingdom, the company provides comprehensive regulatory support to the global pharmaceutical industry. As of November 2017, TRAC Services Limited operates as a subsidiary of PharmaLex GmbH, enhancing its capabilities in navigating complex regulatory environments.