Areas of Expertise
Drug development success starts with the selection of the right molecule. Our experts design and execute a variety of studies aimed at rational lead selection/optimization based on pre-established target product profile.
Comprehensive preclinical research is critical to your Investigational New Drug Application (IND). We provide the expertise, the resources, the experience, and the project team to design, oversee, and execute complete IND-enabling programs.
CMC & Quality
From sourcing starting materials to formulating your drug product, we provide the expertise you need in chemistry, biology, formulation, and manufacturing of both small and large molecules. Experts in each arena of CMC assure not only the quality of your product but the efficiency of its creation.
Just as important as knowing what you need to do at each stage of development is knowing what you don’t need to do for a start up with limited funding. Our seasoned regulatory experts have shepherded dozens, if not hundreds, of new and repurposed drugs through INDs, NDAs, and BLAs and will find you the quickest and surest path.
Our project management team implements a coordinated structure from drug discovery, through preclinical research, to the clinical trials stage. This management ensures a smooth navigation through a multitude of tasks during a product’s progress towards a marketplace launch.
To suit our clients’ needs, we generate strategic plans with various levels of detail, from “30,000 foot” overviews for presentation to investors, to multi-tiered Gantt charts with hundreds of detailed tasks ready to be executed by project managers. Our plans can be tailored to a specific near-term goal or can incorporate all aspects of development: all disciplines and all phases.
PharmaDirections staff have been inventors on dozens of issued patents and applications for our clients. Our policy on intellectual property is simple: we invent; you own. Whatever we invent on your behalf belongs to you, no strings and no royalties attached.
We use sophisticated software packages and internally developed tools to generate predictive pharmacokinetic models that we use to determine optimal dosing regimens, design controlled release dosage forms, and assist in generating intellectual property