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Focused expertise in all facets of drug development

Pharma Directions 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.

Drug Discovery
  • Medicinal Chemistry
  • Lead Optimization
  • Target Product Profile
Strategic Planning
  • Defining the Program
  • Outlining non-clinical, clinical and regulatory strategies
  • Developing a timeline and budget
Non-Clinical Development
  • Disposition, Metabolism, and Pharmacokinetics (DMPK)
  • Non-clinical pharmacology
  • Safety pharmacology
  • Toxicology
Drug Substance Development
  • Identifying Vendors
  • Developing scalable synthesis route
  • Analytical method development
  • GMP manufacturing
Drug Product Development
  • Dosage form selection
  • Formulation development
  • Analytical development
  • GMP manufacturing
Regulatory
  • Regulatory strategy
  • Pre-IND meeting and briefing book
  • IND (and/or IMPD) preparation and filing
Management
  • Program leadership
  • Project management

We’ve worked across diverse therapeutic areas & across multiple modalities

We work across the full spectrum of drug development and regulatory milestones

Drug regulatory milestones

Company Lifecycle

We integrate at diverse stages and enable cost efficient progression to the next stages.

Company Lifecycle

Marketed products we’ve helped develop

Marketed products
Drug Developers

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

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

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

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

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

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

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

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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