Copyright © 2008-2017 JDP Pharma Consulting LLC

Product Concept Evaluation
Technical feasibility assessment 
Preformulation and excipient compatibility study design
Solid-state pharmaceutics data evaluation and interpretation
Amorphous dispersions for dissolution-limited compounds
Formulation and delivery platform selection based on molecule properties
Development of target product profile 
IP strategy development
Patent reviews and evaluation of technical landscape
Life Cycle Management

Product Development
Salt selection, amorphous dispersion, cocrystal, and polymorph screening study designs
Design of stage appropriate stability studies
Formulation strategies for toxicological studies for oral products
Formulation and delivery platform design based on molecule properties and clinical data
Integrated formulation development strategy for phase 2/phase 3 studies
Quality by Design (QbD) focused product development
Sourcing and oversight for API procurement
Selection and oversight of CMDOs 
Material and vendor selection for excipients
Development of life cycle management opportunities

Process Development
Commercial manufacturing process development
Review and author process validation protocols 
Development stage appropriate specification development for: API, excipients, and product
Review and author formulation and process development reports

Technology Transfer
Transfer of formulation and process to manufacturing sites
Author and review technical transfer documentation