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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

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