||HartmannWillner is an FDA regulatory consulting firm specializing in biologics, biosimilars, biotechnology, and biologic device combination product. Our FDA regulatory consultants offer strategic and technical advice; submission writing; compliance inspections and mock FDA audits; electronic submission services (eCTD), to include filing through the Electronic Submission Gateway (ESG); expert witness services; program leadership and management to the biologics, biotechnology, biosimilar, and biologics/device combination products industries.
Our background in the interpretation and application of FDA laws, regulations, and Guidance gives us a unique strength in understanding and explaining these complex requirements in plain terms. Our FDA regulatory consultant experience in the FDA and industry allows us to understand the needs of our clients and the FDA enabling collaborative relationships.
By May 5, 2017, the FDA requires that New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) be submitted using eCTD format through the Electronic Submission Gateway (ESG). By May 5, 2018, this requirement will apply to commercial Investigational New Drug Applications (INDs) and Drug Master Files (DMFs). This requirement also applies to amendments, supplements, and reports even if the original submission was filed before the requirements went into effect. The FDA submissions that do not adhere to these requirements will not be filed or received by the FDA. Paper submissions will no longer be allowed.
For Medical Devices, FDA requires electronic Medical Device Reporting (eMDRs). Manufacturers and importers must submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. User facilities can also submit eMDR reports, but the final rule allows user facilities to continue to submit paper MDR reports.
Our FDA regulatory consultants paired with our eCTD publishing services can assist you in filing these submissions on time and in compliance with FDA requirements. Outsource your eMDR or eCTD publishing to HW or let us assist you in setting up your system in-house.