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Remediation in drug manufacturing: At HG, we specialize in providing comprehensive support for remediation projects aimed at addressing compliance issues and ensuring regulatory conformance. Whether you're dealing with legacy facilities, regulatory challenges, or quality concerns, our team of seasoned remediation experts and skilled professionals is dedicated to guiding you towards compliance and success.


Offerings Include:

  • Compliance Issue Assessment and Prioritization

  • Remediation Strategy Development and Implementation

  • Corrective and Preventive Action (CAPA) Planning and Execution

  • Regulatory Liaison and Communication (483 response support)

  • Data Integrity Restoration

  • Process and Documentation Remediation

  • Staff Augmentation for Remediation Projects (including support for Manufacturing Oversight)

  • My organization needs training. How do I get started?
    HG offers a number of subject trainings for your organization including but not limited to: Data Governance, GMP, Quality Culture, Quality Assurance, and Data Integrity. If you would like to learn more about coordinating training for your organization, simply email to request a consultation and we will connect you with the Subject Matter Expert on our team who can supply you with a proposal and outline of training options.
  • What size companies do you work with?
    Great question. HG works with all types of pharma, biotech, and medical device companies – from startups to large scale Fortune 500 manufacturers.
  • What geographical areas do you service?
    While HG is based in the United States, we travel around the world to support our clients. We provide both onsite and remote services to support the needs of your organization.
  • Can you provide staffing solutions?
    From time to time, every organization can use some assistance and support. HG can help source appropriate and trained candidates for short-term and long-term resource support in order to help your organization bridge its staffing gaps.


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