FDA Consulting Experts

Some of our best FDA consulting experts have just returned from assignment, and are IMMEDIATELY available to support any projects you have have.

Qualifying our Talent

The core of CA’s best-in-class talent offerings is our proprietary, innovative life sciences quality skills inventory.  Assessing competence in over 225 skill and capability areas, our skills inventory helps CA ensure we provide only the most outstanding consultants for your complex quality, regulatory, compliance and operations needs.  Want some additional detail on how we do it?  LET US KNOW and we’ll walk you through our approach and show you how it drives best fit-to-need in the industry.

Expert engineering consultant and attorney with specialized knowledge and experience in all aspects of FDA quality, regulatory, compliance, operations and law.

Expert at:  regulated manufacturing for pharmaceuticals, medical devices, quality strategy and system design, development and implementation, inspection management and preparation, risk analysis and management, supplier quality, writing for compliance, quality leadership, training program design and development

Highly Skilled at: dietary supplements, food, biologics

 Recent Client Projects:

  • GMP, GCP and GLP training and quality and compliance consulting support for numerous Chinese pharmaceutical and biopharmaceutical companies
  • Multiple counsel-directed compliance support engagements, reducing overall FDA enforcement risk
  • FDA 483 response development and remediation planning for global medical device company
  • Site GMP and quality system assessment and remediation planning at global pharmaceutical contract manufacturer
  • Risk-based quality system solution development for bioactive ingredient supplier to pharmaceutical industry

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Senior consulting expert in compliance, quality (GMP, GLP, GCP), and regulatory affairs.

Expert at:  pharmaceuticals, OTC, dietary supplements, batch records, CAPA, laboratory controls, QA, SOP development, training program development

 Highly Skilled at: analytical chemistry, QC, quality system design, stability programs, mentoring

 Recent Client Projects:

  • Evaluate and assess global QMS document architectures and hierarchies; implement effective re-structuring to improve compliance and execution through simplified processes and procedures
  • Inspection preparation, support through inspections, write responses to various regulatory actions including 483s, Warning Letters, and Consent Decrees
  • Develop manufacturing processes and checklists for Quality oversight for a Client operating under a Warning Letter status
  • Lead a multi-year Quality Management System (QMS) improvement project for several large global pharmaceutical companies, which included strategic planning and execution of enhancing 20+ Quality Systems from in process, governance, and technology
  • Lead the configuration and design of a new enterprise document management system, Veeva Vault QualityDocs, supporting a global manufacturing operation

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Medical device expert focused on quality systems, regulatory compliance, risk management and reliability.

Expert at:  medical devices, audits/assessments, WL and 483 responses, DMFs, DMRs, DHRs, product labeling, metrology/calibration, QA, QC, validation, technology transfer

 Highly Skilled at: implantables, IVDs, AERs, quality engineering

 Recent Client Projects:

  • Catheter Design / Mfg – FDA Warning Letter – Product Remediation / Risk Management SME. Developed compliant and efficient Risk Management program and integrated with QMS processes.
  • IVD Mfg – Quality Lead on IVD transfer to Third Party Mfg. Support the development of product and processes including specifications and Supplier Quality agreements, Integration of Supplier Quality Systems for direct material suppliers and external manufacturer.
  • Implantable Design / Mfg. – Quality System Integration / Harmonization. Field Corrective Actions and Corrections / Removals
  • Sterilization Products Design / Mfg. – FDA Warning Letters. Product Risk Management File correction and Design History File assessments. Preparation for external audit readiness.

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Senior consultant with extensive experience with US and EU cGMP, GCP, GLP and ICH requirements.

Expert at:  pharmaceuticals, medical devices, biologics, inspection preparation, manufacturing engineering, validation, quality systems development, non-conformances, CAPA

 Highly Skilled at: combination products, technology transfer, quality risk assessment and mitigation, statistical process control

Recent Client Projects:

  • Quality and regulatory assessments of client studies, procedures, technology transfer projects, and programs to determine compliance.
  • Exception management system and implementing corrective/preventive action plans to address deficiencies.
  • Quality systems and validation programs – 15 month project with start-up pharmaceutical company with cleanroom and isolator technology developing several combination products.  Conducted quality/regulatory compliance gap identifications and directed gap remediation efforts, preparing for the company’s pending PAI.
  • Multiple regulatory submissions for Class II and Class III Medical Devices

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