Completes Risk Management Matrix

Integrated rolling risk/action/decision (RAD) log pre-IND through launch:
- Regulatory
- Nonclinical
- Manufacturing/release/stability
- Biostatistics
- Quality
- Bioanalytical
- Clinical
- Commercial

Designs scalable Quality Risk Management programs

Designs “living” Target Product Profiles using label as a starting point and adjusting during clinical development for streamlined and focused development/NDA/BLA

Implements translational strategy from preclinical to IND and First-in-Human clinical study.

Manufacturing:
- Process Development
- Technology Transfer (e.g. sterile products)
- Clinical Supply Management
- Scale-up
- Process Validation for launch
- Small and large molecules
- Analytical method development, validation and stability studies
- Post-launch control of product samples and promotional materials

Designs and Tracks Regulatory Strategy

Drafts/reveiws correspondence with FDA

Phase appropriate FDA correspondence from Pre-IND meeting through post-approval

Co-Authors/reviews all sections of NDA/BLA including Integrated Safety Summary, Integrated Summary of Efficacy, CMC and label

Design and Implementation of scalable quality management systems (e.g. Standard Operating Procedures)

GCP/GLP/GMP (collectively “GxP”) Vendor Qualification and Quality Management

International and domestic GxP audits (Qualification, Routine and For-Cause) of:
- Contract Manufacturing and Testing Organizations
- Clinical sites
- Clinical Research Organizations
- GLP study and bioanalytical sites

Writes, negotiates and implements GxP Quality Agreements

Strategies and validation of methods for:
- Biomarkers
- Large and small molecules
- Immunogenicity

Designs Request for Proposals and budget comparisons

Tracks progress, schedule and financial accruals

Implement Responsibility, Accountability (only one), Consult, Inform (RACI) Matrix