Small Molecules Drug Substance CMC advisory & support services

With the aim to support virtual companies in outsourced manufacturing operations in Europe, Oriento developed a team of talented and seasoned experts that can be deployed on a short notice for CMC advisory & support services.

Main activities are described here:

Manufacturing Strategy and Operations

Provide strategic advice and guidance on the stages and costs of Drug Substance development:

  • develop budget and timeline estimates for preclinical development
  • conduct due diligence on an asset as potential acquisition
  • design preclinical proof-of-concept studies
  • design and oversee implementation of manufacturing processes
  • oversee execution of Drug Substance development and stability
  • oversee production of toxicology and cGMP lots
  • Process Development and Optimization
  • intermediate and RM sourcing and vendor screening to ensure continuity of supply through the clinical phases through to commercialization, including regulatory audits and PAI

Outsourcing Support

Identify, evaluate, select, and manage contract manufacturing organizations (CDMOs) for all CMC tasks:

  • select, identify and recommend CDMOs based on fit for project and client
  • review and help negotiate Master Services Agreements (MSAs)
  • manage CDMOs on behalf of client to achieve desired outcome and deliverables
  • oversee and support the following processes:
  • technology selection
  • design and specification for release of bulk drug substance
  • Process Validation
  • commercial manufacturing
  • troubleshooting

Project Integration

Integrate development activities with manufacturing processes. Partner with clients and CDMOs to form an integrated CMC team:

  • coordinate activities of integrated CMC team
  • technical training
  • design and deliver on-site CMC training. In-depth training teaches clients to plan and execute product development and manufacturing strategies, and to integrate CMC activities with regulatory requirements to ensure quality and compliance throughout the product life cycle.