Our Integrated Approach
Regulatory and compliance guidance to growing life sciences companies
Regulatory and compliance guidance to growing life sciences companies
Life sciences companies operate in a complex regulatory environment. Even start-ups know to plan appropriately to secure FDA approval or clearance. Still, many product launches miss investor expectations because pre-launch strategy overemphasizes the regulatory issues related to getting a product on the market without appropriately considering the issues once it is.
While the sales and marketing strategies common in other industries could boost sales, many tactics are restricted or prohibited in the life sciences sector. Further complicating matters, the legal analysis is driven by decades of nuanced sub-regulatory guidance instead of case law, and the consequences for violations are significant.
That is where Razor Legal Solutions can help. We partner with your company to ensure that it operates compliantly while also reaching its business objectives.
Our team has exclusively represented branded life sciences companies, in both in-house and big law firm environments.
Our work has touched hundreds of drugs and devices.
Our experience includes a wide arrange of product categories and classes.
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Our competitive advantage is attributable to three factors—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.
We bring over 15 years of in-house and large law firm experience representing branded drug and device manufacturers. Our work has involved hundreds of products in over a dozen therapeutic areas. In addition to our legal experience, our team has held roles in pharmaceutical marketing, sales, and sales training. Together, these experiences uniquely position us to help clients navigate drug and medical device regulation, compliance, and enforcement.
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“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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