Projects

Some of the recent projects NorthCoast has been involved in to optimize clinical development

Colleagues in Hallway

Global Development Redesign

Streamlined and optimized all drug development processes, spanning trial design, operations, regulatory, safety, and supply.  Focus was on efficiency, compliance, cross-functional collaboration, and communication.  Detailed RACI helps teams better understand their roles.  Done for an emerging biotech in Europe. 

Medicine

Asset Transfer of a Marketed Product

Managed asset transfer of a global product to minimize risk for the acquiring company.  Performed inventory and QC of transferred documents to ensure complete regulatory record, clinical development history, and marketing/promotional collateral was in-place.  Supported product approvals post-transfer and supply continuity planning. 

Startup Team

Regulatory Optimization

Mapped regulatory processes for global Pharma and a CRO to promote repeatability across deliverables and to enhanced compliance.  Optimization included new marking authorizations, ongoing product maintenance, labeling, and MAH transfers.   

Airplane

Global Harmonization

Integrated clinical development processes across regions to accommodate unique local needs while implementing standardized processes.  Result was streamlined process and SOP approach to make resource allocation across regions possible and improved efficiency across all functions.