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Experts in the Path to Approval

As an integrated strategy, regulatory, and development partner, we help our clients navigate the complexities of the drug development process. We translate their innovative science into a differentiated product and accelerate and de-risk development to reach the right patients faster. Insight-driven and creatively bold, we excel in developing and executing customized programs where no playbook exists. Our deep experience with customized pharmaceutical R&D strategies can identify and execute the optimal path to better outcomes.

Understanding the strategic importance of input from regulatory agencies in the product development pathway, we’ve established unmatched experience with the FDA along with proven expertise in the development of medicines to treat patients with rare, chronic, and complex conditions. With frequent interactions across all divisions, we productively engage with regulatory agencies to ensure the best outcomes for our clients and for patients.

By pursuing quality and excellence through scientific rigor, continuous improvement, and precise execution to create extraordinary value, we’ve acquired deep and broad therapeutic experience since our start in 2003.

Focus Areas

Oncology Expertise

Our dedicated team of oncology experts is passionate about partnering to help clients navigate the path to approval and deliver better care to patients.

Oncology

505(b)(2) Expertise

Our multidisciplinary team delivers the expertise to build high-science, bold development strategies, successfully engaging with regulators early and often to drive success.

505(b)(2)

Comprehensive Expertise

Therapeutic Areas

Our team has worked with products spanning 27 therapeutic areas, partnering on more than 100 projects each:

  • Analgesia
  • Cardiovascular
  • Gastroenterology
  • Metabolism
  • Neurology
  • Oncology
  • Women’s health

Specialized Patient Populations, Products, & Pathways

Our team has the expertise to build scientifically credible, customized development solutions across a wide range of programs:

  • Biologics
  • Combination Products
  • Digital Therapeutics
  • DESI Products
  • Emergency Use Authorization
  • Fast Track, Breakthrough, and Priority Review
  • Orphan Drug Designation
  • Pediatrics
  • Rare Pediatric Diseases

FDA Expertise

  • Participated in more than 1,150 meetings across all FDA divisions
  • Contributed to more than 250 NDA and ANDA approvals
  • Achieved a 98% FDA first-pass approval rate