Strategic Regulatory Partnerships
Successful drug development requires more than just following rules—it demands strategic foresight. Choosing the optimal regulatory pathway can shave months off development timelines and save millions in costs. Conversely, a misstep in early strategy can result in costly delays or clinical hold.
RegOps provides senior-level regulatory consulting that helps you navigate complexity. We partner with you to define regulatory strategy, prepare for health authority interactions, and assess program risks. Our consultants bring decades of experience across diverse therapeutic areas and regions, offering the insight you need to make confident development decisions.
Our Capabilities
Strategic support from early development to marketing authorization.
Definition of regulatory pathways, target product profiles, and submission plans. We help you align regulatory milestones with business objectives.
Preparation for and support during meetings with FDA, EMA, and other agencies. We help you craft briefing books and rehearse for successful interactions.
Independent regulatory assessment of in-licensing or acquisition targets. We identify regulatory risks and value drivers in potential assets.
Assessment of eligibility for Breakthrough Therapy, Fast Track, RMAT, PRIME, and other accelerated programs. We support designation requests.
Integrated global regulatory plans that coordinate development activities across US, EU, and other regions to optimize global approval timing.
Strategic review of ongoing development programs. We identify potential regulatory hurdles and recommend course corrections to ensure compliance.
The RegOps Advantage
We bring agency insight and practical experience to your development team.
Strategic Depth
We don't just quote regulations; we interpret them. We help you find creative, compliant solutions to complex challenges.
Agency Insight
Our team includes former reviewers and industry veterans who understand how regulators think and what they need to approve a product.
Practical Focus
We focus on actionable advice. Our strategy documents are practical roadmaps, not academic exercises.
Therapeutic Breadth
Our experience covers a wide range of indications, from oncology and rare diseases to cardiovascular and CNS, bringing relevant case studies to your program.