PharmaLex

NeoHealthHub is a pharmaceutical manufacturing and healthcare service consultancy company focused on serving the healthcare sector. It provides innovative and comprehensive services for market access, data management, and capability development throughout all phases of the pharmaceutical and healthcare brand lifecycle. By leveraging its expertise, NeoHealthHub aims to enhance the effectiveness and reach of healthcare solutions in the market.

Phlexglobal, established in 1997, is a specialist service provider focused on the administrative aspects of clinical trials across the pharmaceutical, biotechnology, medical device, and healthcare sectors. The company offers comprehensive support for various components of the clinical trial process, including document management, ethics committee submissions, pre and post-inspection assistance, tracking systems support, and training. Phlexglobal is recognized for its electronic trial master file services, which utilize advanced technologies to enhance control and efficiency in clinical and regulatory matters. By employing proven artificial intelligence solutions, the company helps clients maintain high standards for completeness, timeliness, and quality in their digital documentation practices, effectively streamlining the management of clinical trials.

leading Spanish health economics and market access consultancies, offers support to clients across all stages, from pre- to post-launch.

It offers a wide range of regulatory, technical, and commercial services for medical devices and medicinal products in the APAC region

Established in 1999, Archemin is a well-established pharmaceutical consultancy based in Mechelen, Belgium.

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.

Biopharma Excellence GmbH, established in 2016 and based in Munich, Germany, offers specialized consultancy services for the development, approval, and partnering of biopharmaceutical products. As a subsidiary of PharmaLex GmbH, the company focuses on assisting pharmaceutical researchers and biotech firms by providing expertise in various areas, including biologicals, antibody-containing products, cell and gene therapies, biosimilars, and vaccines. Their services are designed to enhance analytics and precision medicine capabilities, enabling clients to accelerate drug discovery and development processes while facilitating the delivery of personalized treatments to patients requiring innovative therapies.

BioStat Solutions, LLC, founded in 2001 and based in Frederick, Maryland, specializes in providing analytical services to pharmaceutical and biotechnology companies, as well as to the U.S. Government. The company focuses on the design, analysis, and interpretation of complex data, drawing on its expertise in clinical research, bioinformatics, and translational medicine. BioStat Solutions employs a unique approach called Precision Statistics®, which tailors statistical analysis tools to meet the specific research needs and business objectives of its clients. This method ensures that experienced statisticians, geneticists, and epidemiologists collaborate effectively to deliver relevant insights and help clients navigate the complexities of clinical studies. By leveraging a deep understanding of various disease areas and data types, BioStat Solutions facilitates a swift project initiation and efficient analysis, supporting clients in developing appropriate study designs and conducting validated analyses for regulatory submissions. The company operates as a subsidiary of PharmaLex GmbH.

Regulis is a UK-based provider of pharmaceutical regulatory consultancy services. The company specializes in pharmaceuticals, biopharmaceuticals, medical devices, and cosmetics. By offering expert guidance in regulatory compliance, Regulis assists clients in navigating the complexities of the industry, ultimately supporting their growth and safeguarding their assets.

Arbour Group L.L.C. is a prominent 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 has supported over 250 clients worldwide, assisting them in managing business risk by ensuring compliance with FDA and international regulations, as well as industry best practices. The company's offerings include enterprise software testing capabilities and packaged validation protocols that help clients in the pharmaceutical, biotechnology, and medical device sectors maintain compliance throughout their supply chains. As of February 2020, Arbour Group operates as a subsidiary of PHARMALEX GMBH.

For more than 35 years, A.R.C. Pharma has been servicing the pharmaceutical, biotech & healthcare industry in France

Consulting firm specializing in the pharmaceutical sector with a focus on Regulatory Affairs, Quality Assurance, pharmacovigilance.

We provide high-quality, experienced project management and business process improvement services.

TRAC Services Limited, founded in 2001 and based in Redruth, United Kingdom, specializes in global pharmaceutical regulatory affairs consultancy services. The company provides comprehensive support to drug developers, facilitating the complex process of bringing new drugs to market. By offering integrated solutions and collaborative expertise, TRAC Services assists clients in navigating the challenges of rising research and development costs and increasing regulatory complexities. As a subsidiary of PharmaLex GmbH since November 2017, TRAC Services continues to enhance its capabilities in the pharmaceutical sector.

They combine EU and FDA quality and technical insight with product manufacture, distribution, and post market, quality, compliance.

The provision of advice and support to pharmaceutical companies, medical device manufacturers and the medical and healthcare professions.

NHE experts offer an array of scientific grade services in prospective and retrospective health economics and outcomes research services

Their main area of expertise is US FDA GXP Quality Assurance services.

pharmacoepidemiology and pharmacovigilance services as well as regulatory consulting, including Rx/OTC switches,

the company specializes in regulatory affairs, having a particular strength in medical devices.

specializes in strategic consulting for clinical and non-clinical statistics

Service provider within pharmacovigilance and clinical trial safety since 2004

Jacobsen Advice has grown from a ‘onewoman band’ to a successful regulatory affairs consultancy.