Pharmaceutical Scientist, LLC

Visit us at www.pharmsci.com Pharmaceutical Scientist, Inc. (PSI) is a science driven idea company working with industry leaders to make medicines accessible for over two decades. At PSI, Pharma Comes to Meet Science. From novel bioprocessing to creative challenges to biowaivers to providing expertise in emerging therapeutics, PSI is well-equipped with scores of its own and represented IP, proven record of regulatory approval of complex drugs, and expertise in simplifying submissions to help you reduce cost and time to market—the only metrics that counts. PSI offers a large portfolio of NCEs in the fastest growing field of autoimmune disorders, cancer, cardiovascular diseases, and many more. The PSI difference comes from our teams to take these entities to stages of being candidates, at a much lower cost, without burdening your internal teams. From solid solutions to novel suppository bases, PSI has a large portfolio of formulations that can readily be adopted into your discovery model, as well as allow you to expand your portfolio. PSI has innovated combination therapy, as it is becoming more acceptable to regulatory agencies—we can re-create your brand as it comes to end of life cycle. PSI is clearly a pioneer in the field of biosimilars, having taken many from concept to market. Now PSI is offering a portfolio of $30B+ products. The PSI difference comes in giving you an approved product and also its commercial supply that reduces your financial burden. Our technology portfolio from novel bioreactors to mixing and filtration systems that in use commercially can help you reduce facility cost and assure lowest COGS. The science at PSI becomes abundant with the largest volume of writing and teaching we have done over the past 40 years. From creating “thermodynamic equivalence” to replace bioequivalence to novel analytical methods to demonstrate analytical similarity, our approaches are game changers and loved by regulators. Visit us at www.pharmsci.com

网站

https://www.pharmsci.com

Pharmaceutical Scientist, LLC的外部链接

所属行业

制药业

规模

2-10 人

总部

Deerfield，Illinois

类型

私人持股

创立

1995

领域

FDA、Biosimilars、Generic Pharma、351k、505(b)(2)、Bioequivalency Testing、Biowaivers、FTO、BLA Review、PK PD Protocols、Immunogenicity Study、Complex Formulations、Regulatory、FDA Meetings、Fast to Market、Bioprocessing、COGS Control、NCE、Novel Delivery Systems和Botanicals