Classification comes first
Whether a product is regulated as a drug, a biologic, a device, or a combination determines which center at the FDA leads the review and which pathway applies. The answer is not always obvious, especially for products that combine technologies or for software that analyzes medical information. When it is genuinely unclear, a company can ask the agency for a formal designation. Getting this wrong can mean building a development plan around the wrong set of requirements. It is worth settling before significant money is spent on studies.
Talking to the agency early
The FDA offers ways to discuss a program before a formal submission, including pre-submission meetings for devices and pre-IND meetings for drugs and biologics. These meetings often shape study design and data requirements, and the agency's written feedback becomes part of the record the company will live with. Preparation matters: questions should be specific, and the briefing package should be accurate about what the company knows and does not yet know. Clinical studies of investigational products generally need either an application to the agency or a basis for proceeding without one before they begin. Planning those steps in sequence avoids avoidable delay.
Keeping the record consistent
Regulatory submissions, investor materials, and public statements all describe the same product, and inconsistencies among them can create problems with regulators and under securities rules. Quality systems and documentation practices should start earlier than many companies expect, because data generated without them may be hard to rely on later. We work with your scientific and regulatory staff to understand the product and the plan. In a first consultation we look at how the product is likely to be classified, what interactions with the agency have already taken place, and what is planned next. We then identify where legal review adds the most to life sciences regulatory compliance work that is already underway.
