Regulatory Affairs

NERI understands that sound regulatory strategy must be built into projects from the beginning. NERI helps clients tailor a strategy for their investigational product (drug, device, biologic, combination product) and to meet or exceed the requirements of federal and global regulatory authorities in the US, Canada, Europe, Central and Eastern Europe, Latin America, and Australasia during clinical and post-market phases. NERI facilitates reimbursement issues between our clients and Centers for Medicare and Medicaid Services (CMS). NERI provides regulatory guidance on special populations such as pediatrics and orphan diseases.

Through years of working closely with regulatory agencies, NERI has developed many strong relationships with agency staff and a reputation for thoroughness and attention to detail. NERI helps clients interpret regulations and develop a strategy, guides agency negotiations, writes and reviews applications and submissions, manages the regulatory lifecycle, assists with import licenses, monitors safety surveillance and reporting, manages risk, reviews labeling, performs compliance auditing and training, and validates the processes, facilities, and systems used in any project.

Contact:
Flora Sandra Siami, MPH, RAC
Director, Regulatory Affairs
617-972-3317
ssiami@neriscience.com