Support My Due Diligence
What You Are Dealing With
You are involved in an acquisition and the financial, legal, and commercial workstreams are moving fast. Regulatory and compliance due diligence often gets less attention than it deserves in that environment, and compliance liabilities discovered after a deal closes are expensive, sometimes more expensive than the deal was worth. Open Warning Letters, unvalidated systems, weak quality agreements, or a quality management system that cannot support the combined entity are not problems you want to inherit without knowing their true cost. You need a team that can assess the compliance and regulatory posture of an acquisition target quickly and accurately before you commit.
How We Approach It
We conduct thorough compliance due diligence across the target’s FDA-regulated systems, covering manufacturing, packaging, warehousing, distribution, quality management systems, and supporting computer systems. We identify the gaps, quantify the remediation cost, and give you the information you need to negotiate accurately, plan integration effectively, or walk away with confidence.
What We Have Done
A venture capital firm engaged MEDVACON to conduct compliance and regulatory due diligence on a medical device acquisition target. MEDVACON evaluated quality agreements and analyzed the full compliance and regulatory costs associated with two options for housing the acquired product line, one using a new facility and one using a CDMO. This gave the VC firm the information needed to negotiate from an informed position.
A gene therapy CDMO engaged MEDVACON to conduct due diligence on a potential acquisition target to support Phase 2 and Phase 3 clinical trial manufacturing capability. MEDVACON reviewed QMS policies and procedures, delivered a comprehensive gap analysis, assisted with drafting a quality agreement, and conducted a quality assessment of the drug substance manufacturing operation.