FDA Regulatory Services for Chemical, Biotechnology, and Pharmaceutical Clients

In addition to serving as your IP counsel, we can advise you on state and federal regulatory compliance, assist in inquiries and investigations, and guide you through the regulatory permitting and approval process, including hearings and documentation requirements. We can provide comprehensive counsel to you on all aspects of regulatory compliance and enforcement involving small molecule, biologic, and biotechnical drugs — both prescription and OTC — before the FDA and its counterpart authorities abroad. This counseling includes strategic business planning, product development and testing, submissions, product marketing, regulatory compliance and enforcement, advertisement and promotion, and legislative branch lobbying at both the federal and state levels.