What Life Sciences Startups Need to Know About the FCPA
By: 4/21/2025, Dr. Javon Blackmon
As startups in biotech, pharma, and medtech expand internationally, many don’t realize the U.S. Foreign Corrupt Practices Act (FCPA) could apply to them. Even small companies can face major consequences for missteps overseas.
Here’s a quick primer for startup founders:
The FCPA applies to you if you engage foreign healthcare professionals or government-funded hospitals.
Third-party vendors (like CROs or distributors) can create liability if they offer improper payments or gifts.
Doctors abroad = government officials. Treat all interactions accordingly.
Gifts, cash, or travel perks must be clearly documented and policy-approved.
Investors value compliance. Early FCPA safeguards show you're a mature, scalable company.
Want to avoid risk and build global trust? Regulis Legal can help you launch with an FCPA-ready framework.
Be ethical. Be transparent. Be audit-ready.
How to Prepare for a Government Audit in 2025
4/23/2025, by Dr. Javon Blackmon
Intro: Government audits are on the rise in 2025, with increased scrutiny on life sciences companies due to evolving regulations, post-pandemic protocols, and global compliance alignment. Whether you're facing an FDA inspection, a CMS audit, or an FCPA investigation, preparation is everything.
At Regulis Legal, we help companies turn audit anxiety into audit readiness with proactive planning, documentation, and team alignment. Here's a step-by-step guide to help your organization prepare for any government audit in 2025.
1. Understand Your Regulatory Landscape
Start by identifying which agencies are most relevant to your business:
FDA (product safety, labeling, quality systems)
CMS (Medicare/Medicaid billing and claims)
DOJ/OIG (fraud and abuse, kickbacks, corporate integrity agreements)
SEC/FCPA (foreign payments, anti-bribery compliance)
Tip: Keep a regulatory map handy that outlines your agency exposure by product, service line, and region.
2. Perform a Mock Audit
Conduct internal audits using checklists that mirror government inspection protocols.
Simulate document requests, site walkthroughs, and interviews.
Assign a team lead (e.g. Chief Compliance Officer) and audit response coordinator.
Score your findings and create CAPAs for any gaps.
3. Centralize Documentation & Policies
Government auditors want to see:
Clear, current SOPs
Audit trails and version control
Policy acknowledgment forms
Historical inspection records
Tip: Store everything digitally in a secure, searchable format with designated audit folders.
4. Train Teams on Inspection Protocols
Don’t let your first interaction with an auditor be your practice run.
Train all levels of staff on what to expect during a government audit.
Create talking points and a Q&A protocol.
Assign a "runner" to retrieve documents and escort inspectors.
5. Review Contracts and Third-Party Relationships
Third-party vendors and HCP agreements are a hot audit target.
Review contracts for compliance language and indemnification clauses.
Vet vendor due diligence documentation.
Track payments, transfers of value, and communication logs.
6. Have a Regulatory Crisis Plan in Place
If an audit results in a 483, warning letter, or corrective action request:
Have a CAPA protocol ready
Identify your legal and PR response team
Communicate quickly and transparently
Final Thoughts:
Audit readiness in 2025 isn’t about paranoia — it’s about preparation. With the right systems, documentation, and team mindset, your company can navigate any regulatory review with confidence.
Need help building your compliance playbook?
Reach out to Regulis Legal for a tailored audit-readiness strategy.
Be proactive. Be prepared. Be protected.
5 Common Mistakes in FDA Compliance (And How to Avoid Them)
4/23/2025, By Dr. Javon Blackmon
When it comes to FDA compliance, what you don’t know can absolutely hurt you. From mislabeled products to inadequate SOPs, even the most innovative life sciences companies can find themselves on the wrong side of a 483 or warning letter — not because of bad intent, but because of overlooked details.
At Regulis Legal, we’ve seen firsthand how seemingly small gaps in compliance can lead to major regulatory headaches, delayed approvals, and reputational damage. The good news? Most of these issues are preventable.
Here are five of the most common FDA compliance mistakes we encounter, and how you can avoid them.
1. Incomplete or Outdated Standard Operating Procedures (SOPs)
The Risk: FDA inspectors rely heavily on your documented processes. Outdated, vague, or inconsistent SOPs can trigger serious findings.
How to Avoid It:
Regularly review and update SOPs (at least annually or when process changes occur).
Ensure they are specific, actionable, and aligned with current regulatory expectations.
Train staff and document their understanding and application.
2. Inadequate Training Documentation
The Risk: Even if your staff are well-trained, a lack of proof can lead to citations.
How to Avoid It:
Maintain centralized, up-to-date training logs.
Include onboarding, refresher, and role-specific training.
Tie training modules directly to SOPs and regulatory requirements.
3. Failure to Maintain Proper Complaint Handling & AE Reporting
The Risk: Mismanaged complaints and adverse events (AEs) are red flags that suggest risk to public safety.
How to Avoid It:
Establish a clear complaint intake and triage process.
Document all AEs and responses comprehensively.
Analyze trends for CAPA (Corrective and Preventive Action) triggers.
4. Lack of Document Control and Audit Trails
The Risk: Missing version control, change logs, or audit trails can compromise data integrity.
How to Avoid It:
Use validated electronic systems when possible.
Keep audit trails for document edits, approvals, and archival.
Implement strict version control policies.
5. Poor Preparation for FDA Inspections
The Risk: Many companies don’t train staff on how to respond to inspectors, or keep critical documents scattered.
How to Avoid It:
Conduct mock inspections and role-play scenarios.
Maintain an Inspection Readiness Binder with key documents.
Brief leadership and technical staff on protocols and response etiquette.
Final Thoughts: FDA compliance isn’t just about checking boxes — it’s about building a culture of quality, documentation, and continuous improvement.
If you’re not sure where you stand, download our FDA Audit Readiness Checklist or reach out to Regulis Legal for a custom compliance assessment.
Stay ready, stay compliant.
©Copyright. All rights reserved.
We need your consent to load the translations
We use a third-party service to translate the website content that may collect data about your activity. Please review the details in the privacy policy and accept the service to view the translations.