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Focused expertise in all facets of drug development

From discovery and planning all the way through regulatory, we support small biotech’s with complete and comprehensive drug development — delivering the strategy, team and roadmap clients need to be successful.

  • We create efficiencies by knowing just how to navigate each phase of drug development
  • We help companies with limited budgets maximize resources and create value
  • We rely on a team – 150 associates who satisfy every niche of virtual drug development
  • We provide expert advice steeped in real-world drug development experience
  • We work hands-on to achieve desired biological outcomes
  •  We can provide a full team or simply the individual expert needed which makes us ready from day one

Designing and implementing a comprehensive drug development program.

Yes, we can do that.

  • Medicinal chemistry
  • Lead optimization
  • Target product profile
  • Defining the program
  • Outlining non-clinical, clinical and regulatory strategies
  • Developing a timeline and budget
  • Identifying vendor(s)
  • Developing scalable synthesis route
  • Analytical method development
  • GMP manufacturing
  • Dosage form selection
  • Formulation development
  • Analytical development
  • GMP manufacturing
  • Disposition, Metabolism, and Pharmacokinetics (DMPK)
  • Non-clinical pharmacology
  • Safety pharmacology
  • Toxicology
  • Regulatory strategy
  • Pre-IND meeting and briefing book
  • IND (and/or IMPD) preparation and filing
  • Program leadership
  • Project management
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Drug Developers

We have seasoned experts in many different therapeutic moieties and indications that will strategize and build a full-spectrum team around your innovation to push it forward, into patients and toward approval.

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Program Managers

Our Program Leaders and Project Managers drive the execution of coordinated campaigns from drug discovery to preclinical research to clinical trials.

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Drug Discoverers

Our experts design and execute a variety of studies aimed at rational lead selection and optimization based on pre-established target product profiles.

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CMC Experts & Quality Managers

From sourcing starting materials to formulating your drug product, we provide expertise in chemistry, biology, formulation and manufacturing of both small and large molecules.

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Preclinical Experts

We design and oversee the in vivo and in vitro studies you need to assure regulators your molecule is safe enough to treat humans.

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Predictive Pharmacokinetic Modelers

We analyze PK data and use sophisticated computer tools to design dosage forms and optimize dosing regimens.

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Regulatory Experts & Managers

Our seasoned experts have helped advance countless new and repurposed drugs from investigational applications (e.g. INDs) through to marketing approval in the U.S. and abroad.

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Intellectual Property Inventors

Patent applications are part of regular routine. We generate your IP but we take no ownership stake in it.

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REQUEST A CONSULTATION

Contact Cathi Clark, our VP of Business Development to Get Started!

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