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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

Molecules Security
About

ABOUT

Since 2012, Quality CMC Consulting, LLC has been a trusted partner for clients seeking flexible strategic and operational support in drug development. Quality CMC Consulting understands drug development is the perseverance of problem solving and aligns business objectives to focused solutions that are phase-appropriate and product specific.

 

Led by Founder and CEO, Jessica Blomberg, Ph.D., the company brings over 20+ years of CMC, Quality, and Regulatory drug development experience to the table. Quality CMC Consulting has worked with a diverse range of drug product types, from small start-ups to large pharma/biopharma, spanning pre-IND to commercial stages, with a specialization in outsourced drug development.

 

Dr. Blomberg has been recognized for her outstanding contributions to the industry, including being named the 2020 Life Science Consultant of the year by the Triangle Business Journal and receiving the Community Impact Leader award from the Triangle Leukemia & Lymphoma Society (LLS) in 2022. She is the co-inventor on multiple formulation patents and provides industry training.  Dr. Blomberg is also an active volunteer in various professional groups and currently is a Board of Directors Member at the Astronaut Scholarship Foundation, Board of Directors Secretary & Communication Chair for the PDA Southeast Chapter. Dr. Blomberg has been featured on Lab to Leader Podcast and holds a Ph.D. in Analytical Chemistry from Duke University.

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