Life Sciences Compliance Services

Our approach to compliance

Compliance Guidance for Life Sciences Companies

Life sciences companies are faced with a complex legal and regulatory environment. From securing FDA approval to determining how to launch new products while meeting investor expectations, our clients risk serious pitfalls if they lack the proper guidance.

This is where Razor Legal Solutions comes in. We partner with life sciences companies to ensure they are primed to operate compliantly while pursuing their business objectives.

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We Help You Stay In Compliance

We offer compliance solutions anchored in the Seven Elements of Effective Compliance Programs to meet state and federal compliance requirements and dodge unwanted scrutiny, penalties, and fines. Our compliance services include helping life sciences companies with the following:

Design and implement new compliance programs, assess existing programs, and develop and implement compliance training

We have extensive experience providing regulatory counseling and advice on FDA, fraud and abuse, corporate compliance, contractual relationships, Sunshine Laws, reimbursement, government program price reporting, healthcare data privacy, licensure and accreditation, health reform counseling, regulatory due diligences, MHRA and CE Marking, and more.

Draft policies and procedures to mitigate fraud and abuse risks, and establish organization monitoring and auditing plans

We understand that the laws that impact your company do not exist in a vacuum. That is why we take a holistic approach to law, policy and compliance to provide solutions that help our life sciences clients reach their business objectives. Specifically, we will help you by:

Conduct internal investigations

Leveraging our unique subject matter and litigation experience, we represent our life sciences clients in connection with federal and state governmental investigations, inquiries, settlements, and disclosures.

Develop disciplinary guidelines to address breaches of policies and procedures

Our competitive advantage is attributable to our industry experience, environmental awareness, and business acumen. We help our clients anticipate how current and proposed policy shifts or enforcement trends may impact their long-term goals and propose compliant solutions in light of regulatory constraints.

Specialized Knowledge for Specialized Legal Needs

At Razor Legal Solutions, our knowledge of both government and industry allows us to understand – and to help our clients understand – the business implications of changes in the regulatory and enforcement environment. We are always thinking beyond the question at hand to anticipate our clients' immediate needs and the impact on short and long-term goals. Reach out to us to learn more.

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Testimonials

Success Stories

“Jen is the ultimate professional who can quickly grasp complex topics, simplify them and move productively to collaborative soutions.  I thoroughly enjoyed working with Jen  both for this professionalism but also because of the positivity she brings to her work, she makes it fun!”

“Jennifer’s years of in-house experience have provided her with deep knowledge of FDA, DOJ and OIG requirements and policies with respect to the advertising and promotion of pharmaceutical products as well as sales training materials concerning these products.  As a result, she was able to hit the ground running to provide careful, well-reasoned business-oriented advice in these areas. She has been an incredible asset to our organization.”

“Jennifer Razor is a creative and practical attorney who understands the business challenges as well as the legal risks.  She provides nuanced legal analysis and explains how to apply it to achieve business solutions.”

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