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PHASTAR is a specialist biometrics contract research organization offering statistical consulting, clinical trial reporting, data management and data science services by providing expert consultants and managing and delivering in-house projects, FSP-style arrangements and preferred partnerships. Our number one priority is ensuring on time, quality work: every project undertaken is supervised on methodology and utilizes internal processes designed to guarantee optimal quality, inspired by 4,000 years accumulated technical experience across the company. PHASTAR is headquartered in London (UK) and North Carolina (US) and has 14 offices worldwide.
With over 1,975 employees, it has a presence, through its 13 affiliates in Europe and United States.
Our name, Aptuit, is derived from the words aptitude and intuition, two natural attributes that define our unique approach to providing drug discovery, development and manufacturing support. The name communicates our aptitude for scientific knowledge as well as our intuitive understanding of the needs of the pharmaceutical and biotechnological community. We summon these attributes to clarify current challenges and anticipate those that are to come, always with the determination to find solutions. Since Aptuit was founded in 2004, we have forged a robust expansion of our resources. We are living up to the promise of our name by the ongoing assembly of experienced and talented scientists, and we are supporting them every step of the way with the most advanced resources at state-of-the art facilities. Our corporate tagline - Uncommon Expertise. Exceptional Results - reflects our success in harnessing unique and outstanding strengths in drug discovery and drug development to deliver the results that our clients demand.
Graceway Pharmaceuticals is a Bristol, TN-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate. Our first objective is to apply our core analytical technology to thoroughly characterize the structure of the marketed product. By defining the chemical composition of multiple batches of a marketed product, we are able to develop an equivalence window which captures the inherent variability of the innovator`s manufacturing process. Using this information, we then build an extensive understanding of the structure-process relationship to design and control our manufacturing process to manufacture reproducibly an equivalent version of the marketed product. Where necessary, and as required by the U.S. Food and Drug Administration, or FDA, we will supplement an application with additional supportive structure-activity data (e.g., immunogenicity, pharmacodynamics). Our goal is to obtain FDA approval for and commercialize generic or follow-on versions of complex mixture products, thereby providing high quality, safe and affordable medicines to patients in need.