Compliance Offerings

In 2019 the FDA issued 779 Form 483s (Source: Pharmaceuticalonline.com).

Due Diligence for M&A and Investors

Due diligence is critical in determining the impact of a company’s compliance status on acquisition or investment. Deep-dive examination of compliance, gap assessment and recommendations are frequently required by funding institutions and SEC. CMC Compliance Services can perform due diligence audits for funding or M&A. We can also perform an advance due diligence “systems check” for companies preparing for acquisition, borrowing funds, or for Pre-Approval Inspections.

Quality Agreements

Quality Agreements (QAg) are not just a good idea – they are required by both FDA and EMA. Getting them right can determine the success or failure of a customer-CMO relationship. Attention to detail, ensuring fairness to both sides, all while maintaining regulatory compliance and good business practices, are essential components. CMC Compliance Services has written, reviewed, and negotiated dozens of successful QAgs over the years.

“For Cause” and Remediation Assessment Audits

When you have a problem with a CMO, such as failed batches or chronic quality issues, a “for cause” audit may be the best path to addressing the issues. CMC Compliance Services will perform an in-depth audit, identify the root causes of the issues and make recommendations. In follow-up, a remediation assessment of how well the CAPA were implemented and how effective they are is also recommended.

QMS Assessments (All Systems Focus)

FDA inspections are based on six systems that all pharma companies are expected to have in place:

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Facilities and Equipment
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Materials Management
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Manufacturing
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Laboratory Controls
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Packaging and Labeling
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Quality Management System (QMS)
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All six systems must work together; no system is completely stand-alone. CMC Compliance Services can perform evaluations of each system and how they interface with the other systems, identify gaps in compliance, and make recommendations.

QMS Assessments (Quality System Focus)

The QMS is the overarching system that holds all other systems to account. As such, it is the most important of the six systems because it is seen as the final arbiter of safety and efficacy in drug products. A detailed assessment of your QMS can identify gaps that may be creating issues. CMC Compliance Services will perform the assessment and make practical recommendations, always with the goal of compliance with cost containment.

De Novo Quality Management Systems for Start-Ups

Many a small or virtual start-up has said the same thing “We don’t need to be GMP; we don’t manufacture”. The reality is – as the sponsor and final signatory on batch release – a certain level of GMP compliance IS required. A Quality Manual, policies and standard operation procedures are all required, albeit somewhat different from those of a CMO.

Small and virtual companies often do not have a Quality Assurance unit, simply because the need for one is sporadic. CMC Compliance Services can provide basic SOPs for such companies, tailored to a non-manufacturing, low-infrastructure situation. We can also act as remote interim head of quality.

Responses to 483s, Warning Letters and Untitled Letters

When you receive one of these from FDA you have a very finite period of time to respond to the agency. How you respond can make or break your company. CMC Compliance Services has the experience needed to prepare responses to FDA promptly and appropriately.