Advyzom, a Danforth Advisors company, partners with life science companies to guide regulatory strategy and execution on the path to FDA approval and beyond. Since 2011, the consultancy has served as a primary interface to the FDA on behalf of small to mid-sized biotech and biopharma companies who require a thoughtful, hands-on collaborator to navigate the regulatory landscape.
The Advyzom team has led or supported the achievement of hundreds of regulatory milestones for clients, including INDs, NDA/BLA filings and approvals, and numerous FDA designations to expedite development and approval. Click here to learn more about the company.
How Advyzom Can Help
Regulatory Strategy
With broad expertise in regulatory affairs and drug development, the team guides and supports global regulatory strategy for clients’ development programs. This includes leadership of strategic regulatory plans, advisory to boards of directors and senior management, due diligence, regulatory intelligence, and oversight of labeling strategy and promotional claims.
FDA Liaisons and Submissions
The team prepares for and leads health authority interactions and meetings, serving as US agents to the FDA. This includes all aspects of IND, BLA, and NDA filings and review, as well as critical issue management. The team also advises on clients’ internal regulatory operations structure and processes, and serves as
a regulatory operations interface with vendors.
Document Publishing
The team performs submission publishing for all components of applications, including protocol amendments, information amendments, responses to FDA questions, and Office of Prescription and Drug Promotion materials. Original applications are submitted in eCTD via validated electronic submissions gateway (ESG).
Medical Writing
The team’s scientific and medical writers are highly skilled at interpreting complex data and authoring message-driven documents ranging from IND to NDA. Output includes Investigator Brochures, Protocols and Informed Consent Forms, IND Nonclinical Summaries and Previous Human Experience, IND General Investigational Plans, Clinical Study Protocols/Study Reports, NDA/BLA Nonclinical Summaries, NDA/BLA Clinical Summaries, and FDA Briefing Packages.
How else can we help?
Learn about our additional capabilities