Neil Di Spirito

Leveraging Over 20 Years of Pharma, Biologic, Device Law practice to help Pharmaceutical, Medical Device, Biologics, and Life Science Clients Navigate US Drug, Biological, and Medical Device Law.

Greater Orlando

About

I supply business feasible solutions in an FDA regulatory world… “In addition to a firm interpretation of regulatory law and enforcement defense, Neil is also an important business partner who uses his network and knowledge to help his clients succeed in business. Many lawyers are watching the clock by the minute, Neil is rather investing in relationships.” -A Very Satisfied Client. Prior to becoming an attorney, I was an executive for major pharmaceutical manufacturers in marketing, manufacturing, advertising, FDA regulatory and compliance, new drug approval and worldwide business development. With P & L responsibility, I learned to handle regulation in a compliant, but profitable manner.

Experience

  • Principal at DiSpirito Law PLLC
    Nov 2023 - Present · 2 yrs 8 mos

    I have two decades experience in pharmaceutical, biopharma & medical device law practice. Prior to becoming an attorney, I worked as an executive for major pharmaceutical manufacturers in marketing, manufacturing, advertising, FDA regulatory and compliance, new drug approval and worldwide business development. I successfully negotiated with regulatory authorities to launch many products and manage them throughout the product life cycles. As an attorney, I represent pharmaceutical, biologic and medical device manufacturers in a wide array of matters. I teach the Introduction to Pharmaceutical Law and Medical Device Law Courses to the FDA new hires at FDA Headquarters and to the newly hired lawyers of many of the major drug companies and Pharmaceutical law firms.

  • Partner at Epstein Becker & Green, P.C.
    Sep 2018 - Dec 2022 · 4 yrs 4 mos

  • Special Counsel FDA Law Attorney at Law at Ballard Spahr LLP
    Jan 2015 - Aug 2018 · 3 yrs 8 mos

    I have significant experience in the pharmaceutical industry. Prior to becoming an attorney, I worked as an executive for major pharmaceutical manufacturers in marketing, manufacturing, advertising, FDA regulatory and compliance, new drug approval and worldwide business development. I successfully negotiated with regulatory authorities to launch many products and manage them throughout the product life cycles. As an attorney, I represent pharmaceutical, biologic and medical device manufacturers in a wide array of matters. I teach the Introduction to Pharmaceutical Law and Medical Device Law Courses to the FDA new hires at FDA Headquarters and to the newly hired lawyers of many of the major drug companies and Pharmaceutical law firms.

  • Attorney at Rumberger, Kirk and Caldwell
    2006 - 2014 · 8 yrs

    As an attorney, I represent small to mid-sized pharmaceutical, biotech, OTC, cosmetic, food supplement and medical food and medical device manufacturers in a wide array of matters.

  • Managing Director Asia Pacific Business at Pfizer
    1990 - 2003 · 13 yrs

    I managed the Asia Pacific/Latin America business for Pharmacia/Upjohn (now Pfizer). I rotated through all phases of the drug company including marketing, sales, regulatory, operations, manufacturing, national accounts and new business development as well as many other departments. My experience includes negotiation with regulatory authorities to launch products and manage them throughout product life cycle. I also have vast experience in counseling CEOs and Executive VPs, ministers of health and regulatory agencies.