JDP Pharma
. . . Connecting the Dots . . .

Services

Science-based Product Development

CMC Consulting Services

 

Phase Appropriate Product Development Strategy

  • Provide science-based product development strategy from concept to registration and approval

  • Alignment of development strategies with development phase, plans, and timelines

  • Regulatory assessment and risk management of CMC activities to enable efficient product development

  • Leadership and mentoring of cross functional teams to promote collaboration and team-based product development


Formulation Development

  • Design of phase appropriate stability studies

  • Formulation strategies for toxicological and early clinical studies

  • Formulation and delivery platform design based on molecule properties and available in vivo data

  • Material and vendor selection for excipients

  • Assessment of CMC specifications and critical quality attributes



Drug Delivery and Technology Assessment

  • Provide clients with CMC support for due diligence activities

  • Evaluation of drug delivery technologies to support product or platform acquisitions at any stage of product development

  • Formulation and delivery platform evaluation based on molecule properties and preclinical/clinical data

  • Assessment of drug delivery strategies to support life cycle management (LCM) based on molecule properties and unmet medical need

  • Development strategies for: oral controlled release and immediate release products, pulmonary and aerosol drug delivery products, transdermal products, and ophthalmic drug delivery platforms


Product Concept Evaluation

  • Technical assessment and recommendations

  • Preformulation and excipient compatibility study design

  • Solid-state 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

  • Development of life cycle management opportunities



CMC Regulatory Strategy

  • Authoring and review of CMC CTD-based documentation for all phases of development (US and ex-US filings)

  • Preparation of briefing packages for meetings with regulatory agencies

  • CMC representation at regulatory agency meetings

  • Responses to worldwide CMC regulatory queries

  • Pre-approval inspection and audit preparation

  • CMC section of Risk Evaluation and Mitigation Strategy (REMS) package including abuse liability assessment and alcohol interactions for oral controlled release products


CMC Patent Litigation Support

  • Expert witnessing for formulation development and drug delivery

  • Expert and rebuttal report writing

  • Expert witness depositions

  • Expert witness testimony


 
JDP provides strong technical skills and proven expertise in multiple drug delivery approaches with an understanding of the linkages between pre-clinical, clinical, device development, and CMC product development