Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:
• Analytical Method Development
• Catalysis Screening
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities
Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing
Chemistry Technology Platforms
Aseptic Fill & Finish
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Polymorph Screening
• Powder Filling
• X-ray Crystallography
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier
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.
VetPharm, Inc. is a full-service contract research organization (CRO) dedicated exclusively to animal health. It offers a complete menu of pilot/pivotal/post-marketing clinical trial support services, including protocol development, data form design, investigator recruitment, site qualification, enrollment enhancement, study administration, ICH-GCP training, site monitoring, data management, statistical analysis, medical writing, and regulatory support to pharmaceutical, biotechnical, nutraceutical, nutrition, and device companies in the United States and Europe. VetPharm employs a comprehensive study management system and a consortium of study-ready investigators which facilitate rapid study initiation, accelerated enrollment, and superior results to meet sponsors' critical timelines.
VetPharm has broad clinical trial experience across all therapeutic areas which enables it to undertake virtually any trial and complete it quickly, efficiently, and accurately. VetPharm's investigator consortium includes board-certified specialists in the following disciplines: Behavior, Cardiology, Dentistry, Dermatology, Endocrinology, Gastroenterology, Immunology, Internal Medicine, Neurology, Oncology, Ophthalmology, Radiology, Surgery, Theriogenology, and Urology.
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 3,700 highly qualified people. The Company’s 14 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence.
MedSource, now part of Ergomed, is an award-winning clinical research organization (CRO) that delivers high-quality clinical trials through strong relationships and specializes in oncology, neurology/CNS, and infectious diseases. We have participated in 795+ clinical trials globally; more than 250 of them have been in oncology. Our efforts support biopharmaceutical clients who conduct complex clinical trials in the most challenging disease states and patient populations. Our wide experience encompasses a range of therapeutic areas, product types, clinical trial phases and study designs.
As trusted advisers and leaders in the industry, we know that strong relationships lead to strong results. While our services have expanded through the years, we’ve always kept our clients, employees and trial subjects a priority. With their needs in mind, we match a flexible process with transparency at every step along the way. Our goal is for our clients to return to MedSource whenever they need high-quality clinical trial support, because they know we will always act with their best interests in mind.