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We advance drugs on their path to and through the clinic.

Full-spectrum services and expertise that span nearly every niche in pharmaceutical development.

Discovery support, formulation, CMC, DMPK, toxicology, regulatory, non-clinical development, early clinical development, strategic leadership, global project management. All on your terms. All on your timeline and budget. A vast number of moving parts are involved in getting a new therapy into the clinic, and an even larger number are involved in getting it from First-in-Man to pharmacy shelves. At PharmaDirections, we provide expertise coupled with project leadership and management to help you find the fastest, most strategic and cost-effective path from late discovery to clinical proof-of-concept to approval.

OUR PROCESS

Each molecule is different and warrants its own customized approach. Yet the diagram below represents a typical engagement and journey.

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BIG THINKING. PROVEN EXPERIENCE.

Providing a More Sophisticated Path Through Drug Development

We are the hands-on virtual drug development partner for small, start-up and micro-biotech companies who want to bring innovative concepts and compounds to market and enhance people’s lives.

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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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