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AABB cGMP Consulting Services

Trusted partners that bring you strategic solutions, quality outcomes and exceptional results to meet your business goals.

Our team of knowledgeable experts brings decades of diverse experience and training to your project. Whether you are just starting up or are trying to comply with standards and regulations or need assistance with product development and regulatory approval, we can put you on an accelerated solid path to success.

Our Portfolio of Services

  • cGMP evaluation of facilities, processes and support infrastructure
  • Scale up manufacturing with process development and optimization
  • Evaluation of IND manufacturing facilities for compliance with relevant requirements
  • Pre-submission review and support
  • Regulatory strategy development
  • Evaluation of sterilization, equipment cleaning, personnel monitoring, aseptic processing, lyophilization, quality systems and finishing operations
  • Third party audits of suppliers and contract manufacturing facilities
  • Evaluation and development of contract manufacturing agreements
  • Internal training programs on cGMP production and compliance
  • Business operations and strategic management in the areas of:
    • Strategic planning and marketing
    • IT and financial modeling and analysis
    • Business process engineering and project management
  • Clinical Trial Protocol development and data management
    • Human subjects research protections and informed consent form
    • Chain of custody issues for vein-to-vein cellular therapies
  • Compliance assessment against US FDA, cGMP and GTP regulations, AABB, FACT-JACIE, NETCORD, CLIA , ISO standards and other international regulatory bodies
  • Training and development of staff and management
  • Document design and control
  • Change control processes
  • Corrective and preventive action plans
  • Quality control, product release and quality assurance

Let our extensive team of experts leverage their core competencies to help you.

How We Work

We deliver results based on your unique needs and best practices.

Step 1: Perform an analysis that will help you identify and address areas of concern and put the appropriate plans in place.

Step 2: Develop and execute the plan.

Step 3: Deliver unparalleled results.

Our consultants can assist you with a specific project, a comprehensive business and operations plan or work with you on an as needed basis.

Put your quality system in action

Our field proven approach follows the workflow path, so you will find the resulting system easy and natural to use. Incorporating Lean and Six Sigma concepts into our methodology ensures efficiencies and cost savings.

Our staff of experienced consultants works with the latest information to compare your current processes with state of the art practices and recommends areas for optimization and improvement.

We can audit to any criteria in any country

Our consulting professionals all have hands on experience and have worked in a wide variety of cellular therapy facilities around the world. From multi-center clinical trials using contract manufacturers and small biotech start-ups to blood and to cord blood banks and cell processing laboratories and, marrow transplant clinical facilities we offer a global understanding and the ability to work in any region of the world and between product stakeholders.

Meet the Team

Contact Us

Whether you are trying to resolve an issue or propel your facility to the next level of quality, AABB Consulting Services can match you with the right expert in the cellular therapy field. Contact us today and we will help you get started.