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.  If your Quality System falls short of the requirements under 21 CFR 820, 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.

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 amending the current good manufacturing practice requirements of the Quality System Regulation to align more closely with ISO 13485, organizations must transition (by February 2026) to meet the new requirements under 21 CFR 820, which is newly titled the Quality Management System Regulation (QMSR). We can 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 consequential 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 purposefully analyze your current situation, help answer any questions you have, and work with you to 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, manufacturing and medical device product development 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.  We would welcome the opportunity to put this expertise and experience to work for you to help you resolve Quality System deficiencies.

Failing to address concerns in an FDA Form 483 or Warning Letter can have financial and reputational implications. 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.

Good Laboratory Practices (GLP) Compliance for Academic & Research Institutions

Many academic institutions  struggle with achieving Good Laboratory Practice (GLP) compliance under 21 CFR 58. 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.

Current Good Tissue Practices (CGTP) Compliance

If your facility is involved in the processing, storage, or distribution of human tissues and cellular products, you must comply with Current Good Tissue Practices (GTP) under 21 CFR 1271. We assist with:

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

Quality Management System (QMS) Development, Support & Audits

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

• Full QMS development and implementation tailored to your organization.
• Set-up and manage your design controls and the design history file.
• Creating appropriate and regulated documentation of your device during development can be an overwhelming experience. There are several commercial software systems available to help manage your design history file (DHF) or alternatively, you can create a system designed for your needs.  Regardless, developing a relationship with a partner that has managed creation of design controls through best practices is prudent.
• 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 Management Systems post-acquisition.
• Aligning processes, training, and documentation across merged entities.