Our Services
Regulatory Affairs
The complete practice — strategy, submissions, agency interactions, and the specialized science — each service led by a senior operator who has held the seat inside industry.
Our Services
The complete practice — strategy, submissions, agency interactions, and the specialized science — each service led by a senior operator who has held the seat inside industry.
The practice
Regulatory affairs is not paperwork — it is the strategy that decides how fast and how cleanly your product reaches patients. Below is the full practice, from setting the route to defending the label.
Which pathway, which region, which precedent — the decisions that shape everything downstream.
Global Regulatory StrategyOne sequencing plan across FDA, EMA, PMDA, and beyond.
European Regulatory StrategyEMA procedures, national routes, and post-Brexit divergence.
FDA Regulatory ConsultingEnd-to-end FDA strategy, from pathway selection to approval.
Regulatory IntelligenceMonitoring that turns regulatory change into lead time.
Accelerated PathwaysBreakthrough, Fast Track, RMAT, and PRIME, stacked in the right order.
505(b)(2) PathwayA reliance NDA built on FDA's prior findings and a bridging study.
Biosimilar StrategyHighly similar biologics via the FDA 351(k) totality-of-evidence route.
Due Diligence & Gap AssessmentsKnow what you are buying, and what an inspector would find.Authored, assembled, published, and labeled to a standard reviewers trust on the first pass.
Regulatory SubmissionsNDA, BLA, 510(k), PMA, and EU filings, engineered for FDA and Europe.
eCTD PublishingSequence-ready publishing that passes first validation.
Regulatory OperationsThe tracking, publishing, and archive engine behind every filing.
Medical WritingDocuments a reviewer can approve, not just read.
Regulatory LabelingCore data sheet to country label, kept in lockstep.The interactions where programs are made or delayed — and the payer case that follows.
CMC, nonclinical, evidence, and the harder combination and diagnostic cases — framed for review.
CMC Regulatory AffairsModule 3 strategy aligned with what the plant can prove.
Nonclinical DevelopmentIND-enabling programs designed to hold up in review.
Clinical Evaluation ReportsCERs that survive notified-body scrutiny.
Combination ProductsDrug, device, or both: one strategy for hybrid products.
Companion DiagnosticsThe assay and the therapy, co-developed to a single approval date.
Advertising & Promo ReviewClaims that sell without inviting a warning letter.
Proof
The leaders who run these engagements have sat on the sponsor side of the table — inside device, diagnostics, and pharma organizations, and across the desk from the agency itself. They bring the judgment that only comes from having been accountable for the result.
See the work in selected engagements →Work With Us
Tell us about your asset, your target markets, and where your evidence stands. We'll map the fastest credible route and match you with a principal lead — usually within one business day.
Start the conversation
