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Focused
Phase-Appropriate
Compliant

An award-winning drug development consulting company providing focused solutions that are phase-appropriate while applying a balanced interpretation of regulatory expectations and risk. 

Molecules

SERVICES

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Technical Operations

​Manufacturing
  • Vendor Selection (global or regional)

  • Formulation & Process Development

  • Clinical & Commercial Manufacturing (sterile & nonsterile)

  • Technical Transfers & Scale-up

  • Process Validation / Commercial Readiness

Supply Chain / Operations
  • Supply / Commercial Agreements

  • Supply Chain Design & Adaptable Vendor Management

  • Clinical Trial Supply Management

  • Due Diligence / M&A Support

Quality Control (QC)​
  • Method Development, Qualification & Validation for Various Product Forms (small molecules, mAb, AAVs, proteins, VLP, etc.)

  • Phase-Appropriate Item Specifications & Global Control Strategy 

  • Reference Standard & Characterization Program

  • Shelf-life Determination

Quality Assurance (QA)
  • Phase-Appropriate QMS Establishment & Management 

  • Vendor Management & Audits (GLP, CGMP, GCP)

  • Lot Release & Disposition

  • Training 

Hand turning knob to select phases of vaccine clinical trial. Focus on postmarketing surve

Quality Unit

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Regulatory

  • Strategic &/or operational support

  • Compliance road-map design that balances global/regional regulatory expectations and risk 

  • Streamlining global CMC development for efficient regulatory review and approval

  • Author/review CMC sections for pre-INDs, INDs/CTAs & amendments, new marketing applications and supplements/variations

  • Participate in regulatory agency CMC meetings 

  • Product lifecycle management

  • Acting/Interim Heads for short term or long term, pending Client's needs

  • Navigate multiple, fast paced projects that have shifting priorities

  • Roles Served:

    • Head Technical Operations/CMC

    • Head of Quality Unit and CMC Regulatory

    • Head of Quality Assurance

    • Head of Analytical Development and QC

    • Head of Quality Unit

Team Meeting

Acting/Interim Head

About

ABOUT

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