We specialize in providing technical expertise for FDA regulatory submissions, US PTO patent applications, and civil and criminal litigation where chemical identification may be at issue.
LITIGATION SUPPORT
We offer specialized support for clients involved in civil litigation and criminal prosecutions where chemical identifications are critical. Our firm provides unparalleled technical expertise in reviewing evidence, including evidentiary testing procedures and laboratory results. With a team comprising PhD-level chemists and experienced lawyers, we ensure that the scientific aspects of your case are meticulously examined and accurately represented.
IP SUPPORT
We provide specialized support to clients seeking patent protection for their innovations in the chemical and biochemical arts. Our boutique consulting firm is adept at navigating the intricate processes of the United States Patent and Trademark Office (USPTO), offering a range of services designed to strengthen and expedite patent applications. Our team brings a wealth of technical expertise to preparing patentability opinions, drafting utility applications, and formulating detailed technical arguments in response to PTO office actions.
PHARMACEUTICAL AND MEDICAL DEVICE SUPPORT
We specialize in guiding clients through the complex landscape of regulatory submissions to the US Food and Drug Administration (FDA). Our expertise encompasses the preparation and support for New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Investigational New Drug Applications (INDs). We understand the critical importance of complying with current Good Manufacturing Practices (cGMPs) and offer comprehensive services to ensure our clients meet these stringent requirements.
We meticulously review testing data to ensure your regulatory and patent applications and legal arguments are for completeness and accuracy and that they are underpinned by robust scientific principles.