We support programs moving into pivotal trials, validation, and beyond — helping clients prepare for launch and ensure commercial readiness through expert-driven execution and partner coordination.
Our capabilities include:
Process Validation & PPQ Campaigns
Support for commercial process design and scale-up
Preparation and execution of Process Performance Qualification (PPQ) campaigns
Documentation of continued process verification (CPV) strategies
Regulatory Support for NDA/BLA Filings
Late-stage gap analysis and dossier consolidation
Authoring or reviewing CMC sections (NDA, BLA, MAA) including stability, comparability, and control strategies
Commercial Manufacturing Readiness
Supplier/partner qualification, quality agreement support, and technical audits
Dual-site readiness planning and alternate site validation
Operational excellence and lean manufacturing strategy development
Strategic Partner Transitions or Dual-Source Planning
Mid- or late-phase CDMO transitions with minimal program disruption
Support for dual-source validation and technology bridging
Risk mitigation planning for supply continuity
Lifecycle Management & Market Support
Post-approval variation support and regulatory maintenance
Process improvement, yield enhancement, and cost optimization initiatives
Commercial supply chain and logistics oversight (where applicable)
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