TRP's founders have a proven track record in all phases of regulatory documentation production and submission. Our substantial experience allows us to provide quality and efficient service in a timely manner. We are flexible and adapt to our clients' needs.
Demetric has worked in the pharmaceutical sector for 20 plus years. Over the years Demetric has led the Quality Assurance department of the TRP organization ensuring all documents are processed according to eCTD specifications as implemented by The International Conference on Harmonisation (ICH). Demetric has participated on the submission of multiiple Investigational New Drug Applications (INDs) New Drug Applications (NDAs) specializing in the processing of multiple Case Report Forms and Clinical Study Reports. Some of her additional accomplishments can be viewed via LinkedIn.
Irisha Johnson, RAC
With over 15 years of professional experience in regulatory environments, Irisha has been on the front lines of the ever changing regulatory landscape of Covance Inc, GlaxoSmithKline, and Gilead Sciences. Transitioning to a Regulatory Submissions Publisher at the onset of FDA's electronic initiative, Irisha is a subject matter expert in the field of electronic submissions. She has managed the publishing and successful submissions of various types of US and Canadian submissions, including NDA's, INDs, CTAs, sNDA's, and sNDS's with a specialization in Chemistry Manufacturing and Controls. She has helped to implement electronic processes within her organizations and transitioned over 100 applications from paper to electronic with regulatory authorities. Irisha holds Associates of Applied Science in Computer Information and her Bachelors of Science in Business Management. Please learn more about her experience via LinkedIn.
Donna T. Staton
Donna continues to utilize her two decades of regulatory experience to teach, develop, and leverage strong technical proficiencies that translate into producing quality submission-ready documents and utilizing applications that contribute to successful regulatory submissions. Whether it is preparing and submitting complex documents for regulatory approval based on comprehensive knowledge of agency requirements for successful publication approval, project management and interdisciplinary team collaboration, or effectively prioritizing workflow to deliver products on time with exceptional quality. Donna enjoys the deep appreciation of colleagues and clients for her abilities to drive processes, motivate cross-functional teams, and work well under pressure to manage and meet multiple project deadlines. See more on Donna via LinkedIn.