PharmaLex

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 offers consulting services and strategic advice in regulatory affairs and product development.

BioStat Solutions, Inc. (BSSI) provides innovative expert-level statistical analysis and strategic consulting to the pharmaceutical and biotech industries as well as to the US Government. BSSI has its roots in the National Cancer Institute, where its President and CSO did her post-doctoral training. BSSI was established in 2001 based on the need for statisticians and clinical investigators to be able to communicate effectively in order to make smart decisions in the analyses and interpretation of clinical studies. BSSI’s Precision Statistics® approach provides the client with an individualized approach where statistical analyses tools are carefully matched to the research needs and business objectives of the client. In this approach, our statisticians function as a team to provide relevant information to our clients and assist in the interpretation of statistical findings that helps answer the “so-what” question. Unlike typical Clinical Research Organizations (CROs), BSSI provides access to a pool of highly experienced statisticians, geneticists and epidemiologists, using a composite FTE (Full Time Equivalent) model, thereby making sure the right expertise is available for each individual project. Statistics by itself is merely a tool. Thorough background knowledge in most disease areas and experience with virtually every data type guarantees for a quick project start and no time wasted with “getting the statistician up to speed”. Whether a client is working with novel data (e.g. Next-Generation Sequencing data) in the precision medicine arena or entering new regulatory terrain (e.g. licensure under the FDA Animal Rule), innovative strategies are required to help navigate these challenges. BSSI’s Precision Statistics® approach supports clients towards developing the right study design, and implementing the appropriate analytical approach, with validated analyses appropriate for regulatory submission. In other words, The Right Analysis using the Right Tools for the Right Data.

Regulis specialising in pharmaceuticals, biopharmaceuticals, medical devices and cosmetics.

Arbour Group is a leading provider of regulatory compliance products and services for the life sciences industry. They have assisted over 250 clients worldwide with the management of their business risk by assuring compliance with applicable FDA and international regulations as well as industry best practices. They have the warranted solutions for managing global compliance across the end-to-end supply chain. A cornerstone of their offerings is their enterprise software testing capabilities. They possess the knowledge base, resources, methodologies and tools necessary to ensure high quality testing required for data center, infrastructure or applications layers.

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.

Introducing a new drug to market requires a complex interplay of multiple activities and disciplines. For a successful launch, drug developers need a partner that offers holistic solutions and collaborative expertise to help them overcome rising R&D costs and growing regulatory complexities. That’s where a foresighted approach, such as Integrated Product Development (IPD), can make the difference.

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.