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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.


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



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.

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.

Program Managers

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

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.

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.

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.

Predictive Pharmacokinetic Modelers

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

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.

Intellectual Property Inventors

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



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

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