End-to-End Regulatory & Clinical Expertise
From first IND to post-approval lifecycle management, we provide the strategic and operational support your program needs at every stage of development.
Regulatory Strategy & Submissions
Our regulatory team brings decades of FDA experience — including former reviewers from CDER and CBER — to every engagement. We build strategies grounded in science and shaped by real knowledge of how FDA thinks.
Regulatory ServicesIND Preparation & Management
Complete IND preparation including pharmacology/toxicology summaries, CMC sections, and Phase I protocols. Ongoing IND management and annual report support.
NDA / BLA Strategy & Filing
End-to-end NDA and BLA strategy, from pre-submission planning through eCTD assembly, submission, and FDA liaison during review.
FDA Meeting Preparation
Type A, B, and C meeting request preparation, briefing documents, and meeting management. We help you get the most out of every FDA interaction.
Regulatory Pathway Analysis
Accelerated pathway assessment for Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations.
CMC Regulatory Support
Chemistry, Manufacturing, and Controls strategy and documentation for small molecules, biologics, and combination products.
Post-Approval Lifecycle Management
Labeling updates, post-marketing commitments, REMS development, and supplemental application strategy.
Clinical Trial Design & Execution
Our clinical operations team has activated sites across six continents and managed trials from Phase I through Phase IV. We bring the infrastructure and expertise to keep your program on time and on budget.
Clinical Trial SupportProtocol Design & Development
Scientifically rigorous, operationally feasible protocol development with built-in FDA alignment and adaptive design capabilities.
CRO Selection & Oversight
Vendor selection, contract negotiation, and ongoing CRO oversight to ensure quality and accountability throughout your trial.
Site Activation & Management
Site identification, feasibility assessment, activation, and performance management across global site networks.
Patient Recruitment Strategy
Data-driven recruitment planning, digital patient identification, and site-level support to hit enrollment targets.
Data Management & Biostatistics
EDC setup, data management plans, statistical analysis plans, and CSR writing by experienced biostatisticians.
Safety Monitoring & Pharmacovigilance
DSMB/DMC support, safety reporting, and pharmacovigilance systems for IND-stage through post-marketing programs.
How We Engage
Discovery call
We start with a complimentary call to understand your program, timeline, and specific challenges.
Proposal & team match
We propose a scope of work and match you with the senior team members best suited to your program.
Embedded engagement
Our team integrates with yours — attending meetings, reviewing documents, and driving deliverables.
Milestone delivery
We measure success by your milestones: cleared INDs, approved NDAs, enrolled patients.
Not Sure Where to Start?
Tell us where your program is and what's blocking you. We'll recommend the right service and the right team member for your situation.
Talk to an Expert