PharmaDirections, Inc.
PharmaDirections is a virtual drug development partner specializing in guiding small, start-up, and micro-biotech companies through the complex process of drug development. With over 20 years of experience, they offer expertise across nearly every niche in pharmaceutical development, including discovery, formulation, CMC, DMPK, toxicology, regulatory, non-clinical, and clinical development. Their mission is to provide a sophisticated, flexible, and tailored path to bring innovative drug concepts to market efficiently and cost-effectively.
Industries
Nr. of Employees
small (1-50)
PharmaDirections, Inc.
15100 Weston Parkway, Suite 101, Cary, NC 27513
Products
Drug Development Services
PharmaDirections offers comprehensive drug development services, including strategy formulation and team building for drug innovation.
Program Management
Program Leaders and Project Managers coordinate drug discovery, preclinical research, and clinical trials.
Drug Discovery
Design and execution of studies for lead selection and optimization based on target product profiles.
CMC and Quality Management
Expertise in chemistry, biology, formulation, and manufacturing of small and large molecules.
Preclinical Studies
Design and oversight of in vivo and in vitro studies to ensure drug safety for human treatment.
Predictive Pharmacokinetic Modeling
Analysis of PK data to design dosage forms and optimize dosing regimens.
Drug Development Services
PharmaDirections offers comprehensive drug development services, including strategy formulation and team building for drug innovation.
Program Management
Program Leaders and Project Managers coordinate drug discovery, preclinical research, and clinical trials.
Drug Discovery
Design and execution of studies for lead selection and optimization based on target product profiles.
CMC and Quality Management
Expertise in chemistry, biology, formulation, and manufacturing of small and large molecules.
Preclinical Studies
Design and oversight of in vivo and in vitro studies to ensure drug safety for human treatment.
Predictive Pharmacokinetic Modeling
Analysis of PK data to design dosage forms and optimize dosing regimens.
Services
End-to-end outsourced program leadership integrating a virtual team of senior experts and associates across development stages.
Project leadership and coordination across discovery, nonclinical, CMC, DMPK, and clinical activities to execute development campaigns.
Design and execution of studies for rational lead selection and optimization informed by target product profiles.
Sourcing of starting materials, formulation design, and manufacturing planning for small molecules and biologics.
Design and management of in vitro and in vivo studies, toxicology programs, and nonclinical development activities to support human trials.
PK data analysis and predictive modeling to inform dose selection and regimen optimization.
End-to-end outsourced program leadership integrating a virtual team of senior experts and associates across development stages.
Project leadership and coordination across discovery, nonclinical, CMC, DMPK, and clinical activities to execute development campaigns.
Design and execution of studies for rational lead selection and optimization informed by target product profiles.
Sourcing of starting materials, formulation design, and manufacturing planning for small molecules and biologics.
Design and management of in vitro and in vivo studies, toxicology programs, and nonclinical development activities to support human trials.
PK data analysis and predictive modeling to inform dose selection and regimen optimization.
Expertise Areas
- Clinical trial management
- Drug discovery and lead optimization
- CMC and formulation development
- Preclinical development and toxicology
Key Technologies
- Pharmacokinetic (PK) modeling
- DMPK assays and analysis
- In vitro and in vivo nonclinical models
- Formulation development for small molecules and biologics
News & Updates
Xycrobe Therapeutics received the 2016 California JumpStart Grant from PharmaDirections and CLSA, which provides a detailed development plan to assist in regulatory strategy.
Xycrobe Therapeutics received the 2016 California JumpStart Grant from PharmaDirections and CLSA, which provides a detailed development plan to assist in regulatory strategy.