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