We'll work with you in both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and carefully develop due diligence strategies. Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.
Our experts prepare all major regulatory submissions and provide extensive quality control review for all trial-related documentation, such as:
Working collaboratively, our regulatory specialists coordinate all aspects of your trial’s document collection and submissions, including:
Our team of experienced regulatory scientists can write the nonclinical, clinical, and CMC sections in CTD and traditional format for your new drug and biologic applications.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in aggressive and complicated areas.
The Functional Service Program (FSP) is a bundled engagement option that consolidates your externally-sourced projects through a single vendor in The FDA Group. By streamlining vendor management, our FSP eliminates inefficiency, reduces budget overruns, and provides high-quality services from the industry's top talent. Discounts scale with the size and duration of the service package and include a Total Quality Guarantee to ensure reliable service.
