Remediation and Integration

Helping you maintain compliance, reduce risk, and ensure quality excellence

Our Specialized Quality Management Services

In today’s highly regulated life sciences industry, maintaining a robust Quality Management System (QMS) is essential for compliance, operational efficiency, and business success. Whether you need part-time quality support, regulatory transition assistance, or post-acquisition integration, our expert QMS solutions help you stay compliant while optimizing your quality processes. Our team has extensive experience in regulatory compliance, quality management, and life sciences industries. We provide customized solutions that are tailored to fit your organization’s unique needs and challenges. Our flexible engagement options are available for short-term projects, ongoing support, or full-scale QMS development.

Not every organization requires a full-time quality team. We provide experienced quality professionals to support companies in:

• Academic settings that require periodic quality oversight.
• Small or growing organizations that need temporary quality support.
• Companies facing staff shortages or interim quality leadership gaps.

FDA Migration to ISO 13485 Compliance

With the FDA aligning its Quality System Regulation (QSR) with ISO 13485, many organizations must transition to meet the new requirements. We help:

• Evaluate your current QMS and identify gaps in compliance.
• Develop a transition strategy to meet ISO 13485 standards.
• Implement necessary documentation, training, and process updates.

FDA Warning Letter Support

Have you been issued an FDA Form 483 or Warning Letter? We can relate to how stressful and serious this situation is for a company, as our team has been through this process with many people and organizations – including the medical device division of our parent company. We will quickly and deliberately analyze your current situation, try to answer any questions you have, and help you develop and implement a remediation plan that resolves FDA’s concerns and aids in the prevention of future deficiencies.

Our FDA remediation services team, consisting of regulatory, quality system, manufacturing and medical device R&D experts, will help guide you through the 483/Warning Letter resolution process. Our team can help update your product Design History File to meet current standards and comply with quality system requirements. If your Quality System falls short of the current Quality System Regulation (QSR), we can help you bring it into compliance.  We have over 30 years of experience interacting with senior-level FDA personnel on legislative, standards, and regulatory questions, including compliance questions, so we can provide help at whatever level is needed.  We would welcome the opportunity to put this expertise and experience to work for you to help you resolve the Quality System deficiencies.

Failing to address concerns in an FDA Form 483 or Warning Letter can have implications both financial and reputational. FDA might seize product, stop distribution or require a product recall. We have the resources, experience, and processes to help you resolve the issues.

To resolve your deficiencies efficiently, we carefully take the following steps:

1.      Analyze the FDA form 483 or Warning Letter;
2.      Interview key members of your team and review supporting documentation
3.      Answer any questions you have about your situation;
4.      Develop and implement a custom remediation plan, with a timeline that meets expectations, based on your unique situation.
5.      Help you manage the remediation plan, adjusting as new information comes to light.

GLP Compliance for Academic & Research Institutions

Many academic institutions and Medical Device (MED) suppliers struggle with achieving Good Laboratory Practice (GLP) compliance. We provide:

• Compliance assessments to identify gaps in GLP adherence.
• Custom QMS frameworks for research and testing facilities.
• Training and documentation support for full GLP implementation.

Good Tissue Practices (GTP) Compliance

If your facility is involved in the processing, storage, or distribution of human tissues and cellular products, you must comply with Good Tissue Practices (GTP). We assist with:

• Facility audits and readiness assessments.
• Regulatory documentation and SOP development.
• Staff training and process optimization to meet compliance standards.

Quality System (QS) Development, Support & Audits

A strong Quality System (QS) is the foundation of compliance and operational success. We provide:

• Full QMS development and implementation tailored to your organization.
• Ongoing support and maintenance for existing QMS frameworks.
• Internal audits, supplier audits, and mock regulatory inspections.

 Post-Acquisition Integration & Due Diligence

Mergers and acquisitions bring significant quality and regulatory challenges. We help organizations with:

• Pre-acquisition due diligence to assess compliance risks.
• Seamless integration of Quality Systems post-acquisition.
• Aligning processes, training, and documentation across merged entities.