Remediation Services Process Redesign Services

Eliminate inefficiencies, reduce errors, and accelerate cycle times—while strengthening compliance through intelligently redesigned quality and quality-adjacent processes.

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Where compliance meets operational excellence

Quality processes often evolve through accumulation rather than design. New requirements get bolted onto existing workflows. Technology changes but processes don't. Organizational growth creates bottlenecks. Before long, simple tasks require multiple handoffs, critical activities get buried in bureaucracy, and compliance becomes a burden rather than a business enabler.

Smart process redesign does more than fix problems—it reimagines how work flows through your organization. By challenging assumptions, eliminating non-value activities, and leveraging modern approaches, we help you create processes that are simultaneously more compliant and more efficient.

Our process redesign specialists combine deep regulatory knowledge with operational excellence expertise. We understand both what regulations require and how successful organizations achieve those requirements efficiently.

Our process redesign services include:

  • Current state process mapping and analysis
  • Regulatory requirement analysis and interpretation
  • Future state process design and optimization
  • Workflow automation opportunities identification
  • Risk-based control point optimization
  • Process standardization and simplification
  • Performance metrics and monitoring design
  • Technology enablement strategies
  • Change control and implementation planning
  • Training material development
  • Pilot testing and refinement
  • Post-implementation performance monitoring
  •  strategies
  • Pilot testing and refinement
  • Compliance maintenance during transition
  • Post-implementation support and optimization

How we redesign processes

Our process redesign work typically follows a three-phase methodology that balances compliance with operational performance.

Phase 1: Assess

  • Map current-state workflows and identify bottlenecks, redundancies, and compliance risks

  • Review regulatory requirements (e.g., FDA QSR/QMSR, ISO 13485, ICH Q10) to ensure alignment

  • Benchmark performance (e.g., cycle time, error rates, resource burden)

Phase 2: Redesign

  • Create optimized future-state workflows that eliminate waste and improve control

  • Integrate risk-based checkpoints and simplify steps for better consistency and compliance

  • Identify opportunities to automate, digitize, or standardize processes

Phase 3: Implement

  • Plan and manage change with SOP updates, training, and phased rollouts

  • Develop role-based training tools and deliver targeted sessions

  • Pilot new processes, refine based on feedback, and monitor performance post-launch

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Process areas we commonly redesign

  • Document control and change management
  • Deviation and CAPA management
  • Complaint handling and investigation
  • Supplier qualification and monitoring
  • Training and competency management
  • Batch record review and release
  • Annual product review
  • Management review
  • Validation and qualification
  • Internal audit programs

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management of Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of remediation requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.


Please contact us to learn more about fulfilling specific process support needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.