- We conduct targeted due diligence on manufacturers, suppliers, distributors, and other third parties operating within FDA-regulated supply chains.
- Our team assesses third party partners, acquisition targets, and strategic relationships to identify potential regulatory and reputational risks.
- We identify potential concerns related to product integrity, regulatory violations, financial misconduct, or supply chain vulnerabilities.
- Our work helps organizations make informed decisions and mitigate regulatory exposure before entering into business relationships or transactions.
FDA Regulatory Compliance + Investigations
Organizations operating in FDA-regulated industries face an increasingly complex enforcement environment. From pharmaceutical manufacturers and medical device companies to food producers and dietary supplement distributors, the consequences of regulatory noncompliance can be severe, including product seizures, import alerts, warning letters, consent decrees, and criminal prosecution under the Federal Food, Drug, and Cosmetic Act.
The Guidepost Solutions FDA Regulatory Compliance and Investigations practice brings together former FDA personnel who have firsthand experience conducting inspections, investigations, and enforcement actions that shape regulatory outcomes. Our team does not simply advise on FDA requirements. We have enforced them.
Whether you are responding to an FDA inquiry, evaluating a potential acquisition in a FDA-regulated supply chain, or seeking to strengthen your compliance posture before problems arise, our experts provide the operational insight and investigative depth that only comes from years inside the agency.
La diferencia de Guidepost
We Were on the Other Side of the Table.
Many consulting firms and law practices offer FDA regulatory guidance based on legal research and policy analysis. Our team brings something different: direct operational experience conducting FDA criminal investigations, performing GMP and GCP inspections, leading enforcement operations, and training the next generation of FDA investigators. We know how the agency identifies targets, builds cases, and makes enforcement decisions because we have done that work ourselves.
This perspective allows us to help organizations anticipate regulatory risk, prepare for government scrutiny, and respond effectively when issues arise.
Nuestras soluciones
- We conduct independent investigations involving potential violations of FDA regulatory requirements and the Federal Food, Drug, and Cosmetic Act (FDCA).
- We investigate matters involving adulterated or misbranded products; counterfeit pharmaceuticals, medical devices, dietary supplements or tampering incidents; supply chain diversion; documentation irregularities, or issues involving regulated food items.
- Drawing on experience with FDA regulatory enforcement and collaboration with the Department of Justice, we assist organizations responding to regulatory inquiries and investigations.
- Our work helps identify root causes, assess regulatory exposure, and support appropriate corrective actions.
- We assist organizations in implementing monitoring frameworks designed to identify compliance issues before they escalate into regulatory concerns.
- Our services may include periodic compliance reviews, risk assessments, and evaluation of internal reporting mechanisms.
- We also support organizations in managing communications with regulators and responding to regulatory inquiries.
- We work with your team to ensure your organization is fully prepared for FDA inspections and regulatory inquiries.
- Our team conducts mock FDA inspections, including reviews of policies and procedures, manufacturing controls, quality systems, and documentation practices.
- We assess operational readiness, identify compliance gaps, and help address potential vulnerabilities before an inspection occurs.
- We provide guidance and training to help employees understand inspection protocols and regulatory expectations.
Who We Work With
- Law firms with FDA practices that need investigative, compliance, or technical support for their clients
- Healthcare systems managing controlled substance and FDA compliance obligations
- Pharmaceutical manufacturers and distributors navigating FDA requirements
- Medical device companies seeking compliance assessments and inspection readiness
- Food and dietary supplement producers responding to or preparing for FDA scrutiny
- Private equity firms conducting due diligence on acquisition targets in regulated industries
- Companies under investigation or responding to warning letters, 483s, or consent decrees
FDA + DEA
A Unified Regulatory Perspective
Many FDA-regulated products, particularly pharmaceuticals, also fall under the jurisdiction of the Drug Enforcement Administration. The intersection of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act creates a complex regulatory environment where enforcement actions frequently involve both agencies, often in coordination with the Department of Justice.
Guidepost is one of the few firms in the country with deep, operational expertise across both FDA and DEA regulatory compliance. Our DEA Regulatory Compliance practice includes 13 former DEA professionals who have conducted more than 200 mock inspections and trained over 10,000 individuals on controlled substance compliance. Combined with our FDA team’s enforcement and investigative background, this unified capability allows us to address the full spectrum of regulatory risk for organizations operating at the intersection of these two agencies.
This is particularly valuable for pharmaceutical manufacturers and distributors, healthcare systems, pharmacies, telehealth platforms, and private equity firms with portfolio companies in regulated industries.
A Resource for Law Firms
We work alongside law firms as an independent investigative and compliance resource. While legal counsel provides regulatory strategy and representation, Guidepost provides the operational expertise to conduct independent fact-finding, assess compliance gaps, perform mock inspections, and build the evidentiary record that supports legal strategy.
For law firms advising clients in FDA-regulated industries, our team serves as an extension of your capabilities, bringing the investigative and technical depth that complements legal expertise.
MSU Institutional Assessment + RAMAGELLAN MonitorshipEmpire/Liberty Review