FDA Regulatory Consulting Firm

FDA Regulatory Consulting Firm

Experience You Can Trust

Strategic and Technical Advice

Welcome to HartmannWillner

We’re here to help you file your submission on time and in FDA compliance.
HartmannWillner is an FDA regulatory affairs consulting firm that offers 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 experience both in the government and industry allows us to understand the needs of our clients and the FDA enabling collaborative relationships.