Life Science Expertise

Discovery, Nonclinical, and Animal Health (D|N|A) Services

We provide comprehensive consulting services that advance candidate products through the discovery and nonclinical drug development continuum to support both human and animal health. Our team is comprised of subject matter experts (SMEs) across all stages of drug discovery, medicinal chemistry, in vivo model development, pharmacology, toxicology, regulatory affairs, CMC, quality, contractual support, due diligence, program management, and strategic business development. We provide a vast array of experience and knowledge necessary to refine strategies, optimize processes, and accelerate concepts into advanced development and ultimately through to commercial assets.

In addition to our human drug development services, we also offer a unique capability to support food producing or companion animal species with expertise in veterinary biologics, anti-infectives, analgesics and pain control, oncology, parasiticides and insecticides for livestock, poultry, equine, and companion animal indications.

Our Discovery, Nonclinical, and Animal Health (D|N|A) Services include:

SME consulting across all stages of drug discovery and early development

  • Structure and ligand-based drug design & modeling
  • Target selection/validation
  • High-throughput screening & hit identification
  • Medical, synthetic, and computational chemistry
  • Lead optimization: potency, selectivity, physiochemical properties, In vitro ADME, & in vivo PK, safety

CMC vendor selection & management, formulation development, process characterization & scale up, quality systems, manufacturing, and cost modeling

SME leadership for nonclinical development

  • Nonclinical efficacy and proof-of-concept
  • Pharmacology and Toxicology
  • Biodistribution

Nonclinical CRO selection & management

Veterinary clinical trial placement, training, and management

On-site study monitoring

Regulatory support and strategic operations

  • Development of content for submissions for Pre-RDA, RDA, Pre-IND, IND, IND amendments, SPA, NDA
  • Development of content for submission for Pre-INAD, INAD, (J)INAD, NADA and ANADA and Veterinary Biologics Product Licenses (VSTA)

Business Development and Strategic Consulting

  • Proposal development
  • Non-dilutive funding
  • Due diligence
  • Market analysis

For more information about how we can help support your Discovery, Nonclinical, and Animal Health needs, please contact Robert Casillas, Ph.D., Director, or one of our team members today.