Key Deliverables
Comprehensive support tailored to your specific regulatory needs.
IND, NDA, & BLA Authoring
End-to-end management of major applications, from initial strategy and content authoring to final compilation and submission.
eCTD Publishing & Validation
Technical preparation of your dossier in the mandatory eCTD format, ensuring zero technical validation errors.
505(b)(2) Applications
Specialized support for streamlined approval pathways that leverage existing data to reduce development time and cost.
Fast Track & Breakthrough Requests
Compelling arguments for expedited programs to accelerate the review of drugs for serious conditions.
FDA Meeting Management
Strategic preparation for Type A, B, and C meetings, including briefing packages and rehearsal sessions.
Our Approach
A proven methodology designed to minimize risk and maximize speed to market.
Strategy & Planning
We define the submission content, timeline, and resource requirements, identifying critical path activities early.
Content Development
Our medical writers and regulatory experts author high-quality summaries and overviews (Module 2) that tell your product's story.
Technical Compilation
We publish documents into the eCTD structure, hyperlinking and validating to ensure a seamless review experience for the FDA.
Agency Interaction
We manage all communications with the FDA during the review cycle, helping you respond effectively to Information Requests.
Ready to Accelerate Your Regulatory Success?
Contact us today to discuss your specific needs and how we can support your goals.