From molecule to market, we journey with you.

Working as an integral part of our client’s team, we navigate a rapidly evolving drug development and regulatory landscape with our multidisciplinary expertise across the length and breadth of the pharmaceutical industry. From scientific modeling and simulation services to regulatory strategy and submissions, we work with our clients in different capacities at any or all stages of their drug development process.

No opportunity too small, no challenge too big.

With over three decades of experience in pharmaceutical research, development and regulation, our experts approach challenges and opportunities across the drug development lifecycle from multiple critical standpoints, enabling 360° insight.

Evolving Product and Regulatory Strategy

We map out the most efficient route from discovery to delivery, unearthing hidden insight along the way. Our team has extensive experience in the drug development regulatory sector, contributing to 400+ NDA/BLAs across therapeutic areas and critical pharmacology and pharmacometrics policies as part of the FDA.

We help clients find the shortest path to approval

Design and deploy trials and studies

Devise registration roadmap for existing and new categories

Execute regulatory submissions: PKPD data and reports, Pre-IND, EOP2 and MIDD and other meeting packages

Assist in labelling and other negotiations

Driving Drug Research and Development

We have worked with leading pharmaceutical innovators, gaining and providing deep experience in drug development. From simple modeling and simulation to its most complex applications that have led to landmark decisions, we have done it all.

Clinical Pharmacology

Built on strong fundamentals, we recommend what studies to conduct, when to conduct them, how to secure study waivers for NDAs, BLAs, ANDAs including 505 (b)(2)s.

FIH SAD, MAD Studies Drug-Drug Interaction, Food-Effect, Pediatric Studies QT Studies

Pharmacometrics

Modeling and simulation helps companies de-risk up to $1.2 billion per product — we offer the gamut of pharmacometric services with the latest technology.

Exposure-Response Analysis Population PK Analysis Clinical Trial Simulation Interim Analysis

Front-end applications

We harness the power of technology, not just to crunch data but to make our insight accessible and actionable. Our in-house developers design dashboards to share complex information and custom reporting tools to support our R&D services.

Architecting Digital Transformation

We help organizations choose and use the best tools for the job. Our teams are equipped with qualified computational systems and leading softwares like NONMEM, R and our proprietary modeling and simulation platform, Pumas. Our laboratories adhere to strict industry-defined SOPs. We can help our clients set up their laboratories, processes and IT infrastructure.

Together we can

Partner with our highly qualified researchers and hone your bench to bedside strategy with us. Together, we can engineer radical medical advances for a healthier world.