Regulatory Services
Partners LLC: Biomedical Consulting

The principals of LSP have a long history of successful interaction with the US Food and Drug Administration (FDA).  They have had major responsibilities in the organization, preparation and submission of several Investigational New Drug (IND)  submissions, as well as New Drug Applications (NDA) and Biologics License Applications (BLA).  They have also organized and participated in numerous teleconferences and in-person meetings, with the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH).

LSP is therefore equipped to provide a variety of regulatory services for your firm.  Included among these are

• Assistance in identifying regulatory issues and challenges involved in the development of a new product

• Formulation of a regulatory strategy to guide preclinical and clinical development in a way that optimally addresses the challenges identified

• Determination of optimal time points during the development process for initiating contact with FDA (or the appropriate foreign regulatory body)

• Preparation for and assistance with inspection visits from FDA and other regulatory agencies

• Assistance in the planning and execution of FDA meetings and teleconferences

• Preparation of documents to support regulatory submissions, including IND, IDE, Drug Master Files, Orphan Drug Applications and approval submissions