PDG assists the pharmaceutical industry to develop and maintain prescription and non-prescription drug products and devices. Not surprisingly, we engage in a variety of regulatory activities involving literature searches and data evaluations to accomplish these tasks.
On any given day you might find our staff developing Pre-IND/NDA meeting packages, developing FDA correspondence and regulatory submissions, updating product labeling, managing signal detection efforts, conducting pharmacovigilance assessments, and developing annual and periodic reports. Of course, all these tasks include literature searches and data evaluation assignments!
If this sounds familiar, please call or click to contact us and we’ll be happy to also help with your literature needs. Our literature search coordinators are experienced across a multitude of projects, including computerized literature searching, managing computer reference services, analysis and summarization of literature, data and information, and preparation of integrated presentations for the US or international authorities. Translation services are provided.
Let PDG help you with these tasks!