Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services.
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APCER Life Sciences provides comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally.
We bring medicinal / scientific expertise through our healthcare professionals & physicians and address full pharmacovigilance requirements for North America, UK & Europe markets. Our clients benefit from our vast experience in regulatory submissions across 100+ countries and consultative approach towards audit /inspection readiness.
Our focus towards Patient safety and Risk profile management makes us the preferred choice for pharma companies who are looking for pre /post marketing compliance & reporting solutions.
We have scalable operations across five global offices which house more than 750 employees: Princeton, NJ, USA; London, UK; Germany, Wan Chai, Hong Kong, New Delhi and Ahmedabad, India.
Fountain Medical Development is a clinical contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services in China, US, Japan, and Europe. FMD has extensive global experience in multiple therapeutic areas. The company has completed dozens of registrations trials which supported marketing authorization applications in US and Europe.
Our people is the basis of our success. The 1,700+ professionals are dedicated and diverse. At any given moment, at least 3 languages are spoken in our 20 offices in Asia, US, and Europe.
FMD is on the forefront of the paradigm shift in global clinical development. The regulatory reform in China has the potential to fundamentally change how an innovative therapy is developed. FMD is on the frontline building and shaping the future.
FMD is large enough to serve 7 out the 10 largest Pharma companies, and nimble enough to customize to the needs of startup firms.
In the US and Europe, FMD is doing business as FMD K&L. In China, we operate under the name FMD. Whatever the names are, the company is managed globally by a seasoned senior management team comprised of industry veterans.
GB PHARMA GROUP is an established and innovative pharma consulting services organization, which, operating in a constantly changing environment as the Life Science sector, has grown over the years. By understanding our Clients' commercial needs, we provide services in the field of Clinical Resaerch, Regulatory Affaris, Pharmacovigilance and Market access.
The Group is structured into three Companies:
GB Pharma Services & Consulting was established in 1999, as CONTRACT RESEARCH ORGANIZATION of the Group specialized in clinical research services.
Over the years the business model has evolved thanks to the involvement of sister companies, as GB Pharma srl, specialized in post-marketing development phases, including Regulatory Affairs, Pharmacovigilance and Market access, and 3B Biotech Research S.a.g.l.,
promoter of a ambitious internationalisation project.
The group concept is based therefore on the continuous development of internal know-how, applied by a well connected and multidisciplinary team, with excellent technical and scientific skills, specific to Pharma industry. Our goal is to maximize the value of our Clients' product portfolio.
Thanks to this corporate sinergy, and to more than 20 years of experience gained in the Life Science sector, we are able to provide a 360° support.
We consider ourselves as “Your Best Partner” and offer a business model based on the establishment of strategic partnership and on the provision of high-added value services to support our Clients during the development, research and marketing programs.
Our services include:
• Clinical trials, RWE, Observational and outcome research (medicinal products, medical devices, food supplements and cosmetics);
• Patient Support Program;
• Market Access;
• Medical writing;
• Pharmacovigilance post-marketing;
• Quality System & Compliance
• Regulatory Affairs.
We are an established all-phase contract research organization (CRO) based in Berlin, Germany.
We provide complete turn-key solutions for all stages of the clinical development process, including data management, biostatistics, clinical and medical monitoring as well as medical writing and pharmacovigilance services.
We are involved in several global clinical trials and – through collaboration with strong partners – has established a position at the forefront of the latest developments in the world of clinical research. We can manage complete clinical projects from initial trial inception through to regulatory submission.
Our experienced team has substantial expertise in the various divisions of clinical research which enables the company to offer services from preclinical to phase I-IV and post-marketing studies for pharmaceutical, biotech and medical device companies.