Services

Cost-effective, tailored, and flexible solution for businesses seeking executive-level legal support without committing to the overhead tied to hiring a full-time legal executive. 

Hourly, flat rate, and subscription pricing models available. 

As an invested member of your leadership team, a fractional general counsel handles your day-to-day legal and compliance support, legal operations. 

From start-ups to medium-sized enterprises, this model provides top-tier legal expertise without exhausting 

your budget. 

Companies of all sizes encounter periodic or project-based legal and compliance support demands. Whether it's building your compliance program, updating  or reviewing policies, drafting and facilitating training, stepping in to help with advertising and promotional materials review (i.e., MLR review), or any other projects requiring legal or compliance support,  

Lapis Legal can help.

Whether you need contracts drafted, reviewed, or negotiated, Lapis Legal works to safeguard your business interests.

Lapis Legal can also create contract management strategies, templates, and playbooks to help maximize efficiency, streamline your processes, and 

minimize risk.

Already have contracts, templates, 

and contract processes? 

Let Lapis Legal review them for ways to maximize protection and create efficiencies. 

The path to innovation requires more than just brilliant ideas. It demands a competitive business and lifecycle strategy. Let us help you navigate the web of regulations that govern your business and provide legal advice and counsel that empowers business decision-making, removes obstacles, creates possibilities, and protects the interests of your company, investors, business stakeholders, and customers.

Advise on R&D Strategy and Tactics

Clinical Trials 

Manufacturing/Tech Ops 

Drug Safety and Pharmacovigilance

R&D and Vendor Contracting

Audits and Regulatory Enforcement

HCP Engagement

Sales Force Training

Fraud and Abuse, Anti-Corruption,

and Anti-Kickback Analysis

Policies and Procedures 

Development and Training

This is not an exhaustive list. Please inquire about your specific needs.

Review and Advise on Medical Affairs and Commercial Strategic and Operational 

Plans and Tactics 

Promotional Marketing Claims Review

Social Media

Strategic Communications

FDA and FTC Advice and Counsel

FDA/Health Authority Labeling

FCPA

PhRMA

Trademarks and Copyrights

Audits and Regulatory Enforcement

HCP Engagement

Sales Force Training

Contracting

Fraud and Abuse, Anti-Corruption,

and Anti-Kickback Analysis

Policies and Procedures 

Development and Training

This is not an exhaustive list. Please inquire about your specific needs.

 HR/Employment Issues

Privacy

Terms and Conditions

Corporate Governance and Process

Third-Party Due Diligence

This is not an exhaustive list. Please inquire about your specific needs.

Risk Mitigation

Compliance Program Development

Compliance Policy 

Development and Training

Code of Conduct and Ethics

Monitoring, Auditing, and Reporting

Internal Investigations

This is not an exhaustive list. Please inquire about your specific needs.

Regulatory Compliance 

Regulatory Engagement Strategy

Product Labeling

This is not an exhaustive list. Please inquire about your specific needs.

The legal and compliance landscape is fraught with an intricate web of laws, regulations, and industry standards that are constantly evolving. Lapis Legal can perform a risk assessment on all or parts of your business to provide an analysis of your company's  compliance health, followed by recommendations on risk mitigation strategies that Lapis Legal can also help you implement.

When crisis strikes, every minute counts for a business and its executives to safeguard their reputation and long-term success. From perception issues to liability concerns, Lapis Legal can help your business and its executives navigate through the toughest storms with transparency, confidence, and resilience.