Remediation Services Regulatory Submission Remediation Services

Salvage stalled submissions and overcome regulatory roadblocks with expert remediation that addresses deficiencies, strengthens data packages, and gets your products back on track for approval.

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When submissions stall, revenue stops

Regulatory submission deficiencies can derail years of development work. Complete Response Letters, clinical holds, refuse-to-file actions, and repeated information requests signal fundamental gaps that simple amendments won't fix. Whether due to data integrity issues, inadequate safety analyses, manufacturing concerns, or clinical study problems, these setbacks demand comprehensive remediation strategies.

The path forward requires honest assessment of deficiencies, strategic planning to address them, and flawless execution of remediation activities. You need teams who understand both the technical requirements and regulatory psychology—who can identify not just what's missing, but why FDA has concerns and how to address them.

Our submission remediation specialists have recovered hundreds of stalled applications. We bring together regulatory strategy, technical expertise, and project management to transform problematic submissions into approvable packages.

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Our submission remediation services include:

  • Comprehensive deficiency analysis and gap assessment
  • Root cause determination for submission failures
  • Remediation strategy and regulatory pathway planning
  • Data integrity review and correction
  • Clinical data reanalysis and presentation
  • Safety signal evaluation and risk communication
  • CMC gap closure and stability strategies
  • Manufacturing remediation coordination
  • Nonclinical study planning and execution
  • Response document preparation
  • FDA meeting preparation and support
  • Resubmission strategy and timing

Submission types we remediate include, but are not limited to:

  • 510(k) submissions
  • PMAs and panel preparations
  • INDs and clinical hold responses
  • NDAs/BLAs and Complete Response Letters
  • ANDAs and DMF deficiencies
  • Post-market commitments

Common regulatory remediation focus areas

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Every stalled submission has a different story—but most require targeted remediation across these key dimensions:

  • Scientific and Clinical Data Gaps

    • Missing or insufficient statistical analyses

    • Safety signal concerns and risk characterization

    • Subgroup inconsistency, unblinded data, or endpoint ambiguities

    • Clinical data reorganization to improve narrative flow and clarity

     

  • CMC and Manufacturing Issues

    • Incomplete process validation, inadequate stability data

    • CMC module inconsistencies with facility capabilities

    • Gaps in batch records, raw material control, or comparability data

    • Coordination with manufacturing teams to close readiness gaps

  • Data Integrity and Submission Quality

    • Discrepancies between datasets and summary documents

    • Part 11/e-source compliance concerns in eCTD files

    • Data traceability issues or improper data pooling

    • Corrections and re-verification of source-to-submission linkages

  • Strategic Repositioning

    • Reframing regulatory pathway (e.g., de novo vs. 510(k))

    • Updating the predicate rationale or clinical bridging strategies

    • Reassessing approval endpoints and risk/benefit positioning

    • Supporting narrative redesign to address FDA tone and concerns

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Why trust The FDA Group with your response?

  • Proven recovery experience: We've successfully remediated hundreds of submissions across INDs, NDAs, BLAs, 510(k)s, PMAs, and more—with a strong track record of turning Complete Response Letters and clinical holds into approvals.

  • Cross-functional remediation teams: Our experts span regulatory strategy, CMC, clinical, biostats, and manufacturing—ensuring coordinated solutions across all technical modules.

  • Former FDA insight: Many of our consultants are ex-FDA reviewers or investigators who understand how regulators interpret deficiencies—and how to rebuild confidence.

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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 FDA Warning Letter 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.