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We act as your champion, from start to finish.

At PharmaDirections, we give our clients the strategy, roadmap and team they need to turn an idea into reality, always being mindful of budget and risk criteria. We identify ways to scale a concept­ — laying out the people and skill sets that will be required, defining the right path to follow and implementing/executing the overall operational game plan.

To get there, we assign a Project Leader to every assignment – someone who will drive the execution of a project by guiding a cohesive team of experts. Moreover, we maintain a staff of PMP-Certified Project Managers who have many years of direct pharmaceutical industry experience.

Do I need both a Project Leader (PL) and a Project Manager (PM)?

You may not. It all depends on the scope of your project. You will always have an assigned Project Leader. Yet in certain situations, typically full development projects, we also assign a Project Manager to ensure that nothing is overlooked and that every task stays on time and on budget.

At PharmaDirections, PLs and PMs have very different roles in the project. The PL is the one who, together with the client, sets the operational strategy and direction for the project and keeps everything on track at the macroscopic level. The PM manages individual vendors and tasks, making sure timelines and budgets are met on the microscopic level.

This paradigm is standard throughout the industry as it leverages the best assets of each resource in a cost-efficient manner.

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OUR PLEDGE TO YOU

By setting reasonable milestones and working hands-on to achieve desired outcomes, we deliver peace of mind and help you move one step closer toward fulfilling your vision.

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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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