Preclinical
Programs

Set your program up for clinical and commercial success.

• Limited internal expertise

  Our integrated teams guide your earliest decisions with cross-functional expertise that aligns science, quality, and long-term objectives.

• Lack of a coherent, forward-looking development plan

  We design and execute forward-looking, risk-managed programs that reduce downstream issues—and speed your asset through development and approval.

• Delays or missteps that could derail timelines or funding

  In drug development, the stakes are high. Our integrated model helps clients avoid regulatory setbacks, quality gaps, and disconnected development plans that could delay key milestones—or jeopardize investor confidence.

• Fragmented planning across functional silos

  We bring together experts in discovery, CMC, regulatory affairs, quality, and medical writing, to guide your program forward as a cohesive whole—ensuring smooth handoffs and aligned priorities throughout development.

• Regulatory uncertainty and evolving expectations

  We help you interpret and apply global regulatory requirements through a fit-for-purpose, risk-based approach grounded in scientific and operational insight. Whether you’re pursuing an IND, NDA, BLA, or global filings, our experts guide you through every step with clarity and precision.

• Complex, time-sensitive submission demands

  Our experienced scientists craft clear, compliant regulatory documents that meet global standards and support every step of the submission process. From authoring and editing to formatting, QC, and coordination, we help clients meet tight timelines for INDs, NDAs, MAAs, and agency briefings—without compromising quality.