Who We Are
The TRP team have a proven track record in all phases of regulatory documentation production and submission. Our combined professional experience allows us to provide quality and efficient service in a timely manner. We are flexible allowing us to quickly adapt to our clients' needs for immediate results.
Triangle Regulatory Publishing (TRP) specializes in Regulatory Operations and Electronic Submissions. Our team will handle the heavy lifting of the electronic submission process which allows Sponsors to focus on the development process. TRP has 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.
Our Commitment to Results
Our organization is comprised of a network of industry experts who specialize in ensuring marketing applications are successfully submitted and accepted. Our team knows how to successfully navigate the ever-changing publishing standards and requirements of the Regulatory Authorities, gracefully managing every detail and deadline using leading industry leading publishing software and submission tools.
We are here to make the management of change painless and the submission process seamless and efficient. We support our clients as they navigate the ever changing regulatory requirements and serve as a bridge between the long-standing and the new. We take great pride in the meaningful relationships we have fostered with our clients while educating and guiding every step of the way.
Meet Irisha Green (Johnson), RAC
With over two decades of professional experience in regulatory environments, Irisha has been on the front lines of the ever changing regulatory landscape of Covance Inc, GlaxoSmithKline, Gilead Sciences and TRP. 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 and the electronic Common Technical Document (eCTD). She has managed the publishing and successful submissions of various types of US and Canadian submissions, including but not limited to NDA's, BLA’s, aNDA's, INDs, CTAs, sNDA's, with a specialization in Chemistry Manufacturing and Controls. She has helped to implement electronic processes within her organizations and transitioned hundreds of applications from paper to electronic with regulatory authorities. Irisha holds an Associates of Applied Science in Computer Information, her Bachelors of Science in Business Management and her Regulatory Affairs Certification (RAC). Please learn more about her experience via LinkedIn.