Kaufman Flynn Consulting Services, LLC

Due Diligence Audits

Through KFCS’s extensive work in compliance and regulatory affairs, as well as the industry and FDA backgrounds of the consultants, KFCS is uniquely qualified to provide expert advice on compliance, scientific, and technical matters by performing evaluations of the following:

  • Assessment of client-targeted organizations and facilities for compliance
  • Identification of gaps in compliance and provision of remediation plans
  • Assessment of management controls
  • Evaluation of executive and management personnel capabilities
  • Evaluation of supply chain and product pipeline capabilities
  • Assistance in addressing regulatory affairs requirements—from strategic advice on regulatory filings to evaluation and resolution of complex scientific and regulatory issues


Training programs can be customized to meet each organization’s requirements. In addition to classroom training, KFCS is also providing on-the-job training and “train the trainer" services. These are some of the training programs KFCS Consultants offers:

  • Essential Programs for Senior and Mid-Level Management
    • Corporate and Individual Responsibility and Legal Liability for Compliance
    • Risk Management - The New Frontier
  • GMP Programs
    • GMP training for manufacturing and laboratory personnel
    • Overview of GMPs for the 21st Century
    • Risk-Based GMP Inspections
    • FDA Pre-Approval Inspections
    • Preparing for an Inspection and Interacting with the Investigator
    • Integrity of Records and Data
    • GMP’s for Dietary Ingredients and Dietary Supplements
  • Regulatory Programs
    • Regulatory Approaches to Product Development, Quality Evaluation and Clinical Assessment
    • Regulatory Aspects of Life Cycle Management

Regulatory Affairs

KFCS' Regulatory Affairs Practice is comprised of former senior-level FDA managers, FDA reviewers, and industry experts. The Regulatory Affairs Practice’s goal is to bring simple, workable solutions to clients' regulatory problems or issues, and has earned a stellar reputation for doing just that. KFCS consistently produces results that move clients to the desired outcome more quickly and efficiently.

The Regulatory Affairs Practice has assisted numerous clients in addressing and overcoming regulatory affairs challenges. The accomplishments below represent a sampling of the results delivered to clients:

  • Prepared and submitted ANDAs and NDAs (including eCTDs), and DMFs
  • Facilitated the timely approval of ANDAs and NDAs, including first-time generic approvals
  • Facilitated the resolution of drug listing issues and related U.S. Customs'detention orders

Quality & Compliance

Our consulting services are characterized by:

  • Knowledge: We know what is important to FDA.
  • Experience: GMP consultants, each with at least ten years in GMP.
  • Approach:  In addition to process and procedures, we review the organization, employee engagement, systems, training, etc.
  • Root Cause Analysis: We focus our resources on determining and rectifying the root cause.
  • Strong Project Management: Regardless of project size, each engagement is assigned a project manager with responsibility for project success, acting as a single point of contact for you and your team.
  • Value: Our consultants are competent and efficient, producing results as quickly as possible. We do not believe, as some of our competitors do, that the best results are obtained by engaging legions of consultants to rewrite SOPs.
  • Speed: Time is critical when manufacturing issues arise. We mobilize quickly to assist our GMP clients worldwide.

Compliance to current Good Manufacturing Practices (cGMPs) is critical to your business, your patients, and an expectation of the Food and Drug Administration.  Today’s pharmaceutical manufacturing is complex and requires significant experience in GMPs to ensure compliance. To comply with the FDA’s requirements under 21 CFR parts 210, 211, 820, and 11, you must have robust quality systems and processes, and a well-defined supplier qualification process. KFCS has the expertise and industry experience to perform and manage these processes for your organization.

Our Quality Gap Analysis experts will spend significant time on-site at your facility examining all aspects of your quality systems and manufacturing operations.  We will work with your organization and review the following:

  • Personnel Qualification and Staffing
  • Quality Manual
  • Change Control
  • Deviations
  • Investigations
  • CAPA
  • Document Management
  • Electronic Quality Management Systems
  • Process Validation
  • Cleaning Validation
  • Equipment Qualification and Validation
  • Manufacturing Batch Records
  • Packaging Batch Records
  • Part 11 Compliance
  • Laboratory Controls
  • Analytical Method Validation
  • Supplier Qualification Program
  • Internal Audit Program
  • Raw Material Testing and Controls
  • Environmental Monitoring
  • Inventory Management

Within the Quality System, we can provide the following services:

  • Policies, Standards, SOP Preparation, and/or Optimization
  • Batch Verification/Certification
  • Quality Systems Development, Assessment, Remediation
  • Root Cause Investigations and Corrective Action/Preventive Action (CAPA) Remediation
  • Third-party GMP and GLP Compliance Auditing
  • Mock FDA/International Regulatory Agency Inspections & PAI Readiness
  • Due Diligence Compliance Inspections, Audits and Assistance
  • FDA Actions (483 Observations, Warning Letters, Consent Decrees) Remediation
  • Data Integrity Compliance

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