About Us

Seasoned, Knowledgeable, Creative Former In-House Attorneys

Who Have Been on the Front Lines of Pharmaceutical, Biotech, Medical Device and Diagnostic : Regulatory IP, LCM, Litigation Support & Transaction Issues.*

  • Our attorneys have experience unique to the pharma and medical device/diagnostic industries
  • We have been outside counsel and/or senior in-house counsel, general counsel and IP counsel
  • Experienced in Intellectual Property, FDA Regulatory, Life Cycle Management, Litigation Support and Business Development (including due diligence, agreements, licensing, acquisitions and divestiture)
  • Long and successful track record of creating strategies to enhance, extend, protect and defend the flagship products of numerous pharma and device/diagnostic companies
  • We speak patent and regulatory legalese, but MOST IMPORTANTLY, business-ese to bridge communication gaps between scientists, lawyers and businesspersons with a commonsense, business-focused approach
  • We evaluate strengths and weaknesses of your IP & regulatory strategies to help maximize product protection by:
  • Identifying IP warts and either recommending fixes or devising strategies to deal with them
  • Identifying new assets and hidden gems
  • finding new patents, regulatory exclusivities and product line extensions and next generation product ideas
  • helping bulletproof your products from infringers
  • preparing for potential generic competition
  • working with outside counsel on effective Hatch/Waxman litigation strategies
  • We can help you update and maintain these assets as your company evolves and can tailor our work to your company's needs, budget and stage of growth

Our Team

Randall J. Zakreski, ESQ.

Years of Legal and Industry Experience: 30+

Position: Co-Founder & General Counsel

Randall J. Zakreski has worked in private practice as a litigator with a major Philadelphia law firm and has worked in general counsel roles of ever increasing importance as a trusted leader, manager and advisor to Senior Management with a track record of success on the full panoply of legal issues for a number of significant pharmaceutical and device manufacturers. In addition to general counsel experience, Randy has also developed particular cutting edge skills in these industries through his focus on issues involving FDA Regulatory, Intellectual Property & Products Liability Litigation, Life Cycle Management, Due Diligence/ Acquisition and Business Development Support.

Randy graduated magna cum laude from Boston College & attended Villanova University School of Law, where he was a member & ultimately Articles Editor of the Villanova Law Review. He was in private practice as a litigator for Montgomery, McCracken, Walker & Rhoads, where he became involved in significant medical device & pharma litigation for various clients, including Pfizer companies. He has served in various general counsel roles of increasing importance for companies such as Boehringer Ingelheim Pharmaceuticals, Inc., Roxane Laboratories, Inc., BenVenue Laboratories, Cephalon, Inc., Teva Pharmaceuticals, Inc. and OptiNose, Inc. Randy is a long time member of both the Pennsylvania and the New Jersey Bars.


His innovative, outside the box thinking helped and/or is helping to preserve or extend the regulatory and IP exclusivity of numerous clients’ flagship and core products, including:

  • °successful litigation &/or management of numerous critical Hatch Waxman, Products Liability, Antitrust, Commercial &/or Whistleblower/ Employment trials/appeals
  • Ground-breaking/Company Transforming Hatch Waxman, Products Liability & other strategies, solutions & settlements re core products drafting and arguing FDA Citizen Petitions advocating important safety and bioequivalence arguments that helped to preserve market exclusivity of a client’s flagship pharmaceutical product for multiple years AFTER the last patent expired
  • design, argument and implementation of successful, novel pediatric exclusivity extension with FDA respecting client's core product
  • investigation of compliance issues/defense of major DOJ off label promotion allegations
  • management of FTC Decision and Order compliance re significant client merger/product acquisition
  • design and implementation of integrated complex product Regulatory, Intellectual Property, Litigation and Life Cycle Management strategy to enhance approval and preservation of market & IP exclusivities of innovative drug/device combo product
  • Randy established Pharmidable Legal Advisors, LLC (formerly "Transpharmativ Legal Advisors, LLC") with former Cephalon colleague Bob Hrubiec, Esq., Ph.D, to provide innovative consulting to small and large pharma and medical device/diagnostic companies.*


You can email Randy at rjzakreski@pharmidablelegal.com or rthrubiec@pharmidablelegal.com or call him at 1-484-883-4522.

Randy also provides general counsel services through a standalone company known as IngeNEWity Legal Consultants, LLC. For a discussion of these general counsel services, please visit www.ingeNEWitylegal.com


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Robert T. Hrubiec, Ph.D., ESQ.

Years of Legal and Industry Experience: 30+

Position: Co-Founder & Chief IP Counsel

Robert T. Hrubiec is a seasoned intellectual property attorney and business executive with over 30 years experience either as a scientist or as in-house counsel for both large and small pharmaceutical and biotechnology companies. Bob applies the powerful combination of his in-house legal experience, scientific knowledge and strategic business perspective to help Pharmidable address Intellectual Property, Regulatory, Litigation, Life Cycle Management, Due Diligence, Acquisition Support and GAP Analysis issues in a practical, no-nonsense, and cost efficient manner.


Bob served as Vice President and Chief IP Counsel of Cephalon, Inc., a mid-sized biopharmaceutical company and as an Intellectual Property Attorney for GlaxoSmithKline, a multi-billion dollar pharmaceutical company.

Bob earned his doctoral degree in Synthetic Organic Chemistry from the University of Connecticut. He also served a post-doctoral fellowship (Pharmacology/Biochemistry) at Yale University School of Medicine and earned his law degree from North Carolina Central University School of Law (evening division). Bob has been a long time member of the North Carolina, Pennsylvania Bar since 2010 and a member of the United States Patent and Trademark Office Bar. Prior to his admission to the Patent Bar, he had various roles as a scientist in academics and the pharmaceutical industry.


Bob’s passion for science, technology and the law along with his entrepreneurial spirit have resulted in smart, strategic solutions to the management of IP, including:°

  • °devising and implementing a combined patent/FDA creative strategy for key products which helped to extend protection for several years
  • identifying and obtaining additional patent claims for major products which helped make the creation of a non-infringing design around more difficult and significantly increased patent protection
  • establishing a Patent Committee that efficiently identified, developed and managed patent filings saving several million dollars in patent costs
  • effectively presenting IP positions of small/mid-size pharma companies to potential investors
  • assisting with patent litigation strategy for a major pharmaceutical product which resulted in solidifying its exclusivity position for several years
  • identifying IP issues with target products/companies as part of prudent investment diligence which significantly reduced the overall acquisition costs resulting in hundreds of millions of dollars in savings
  • receiving the Deals of Distinction award from the Licensing Executives Society which recognized a creative IP-based licensing and business arrangement in the stem cell business sector
  • evaluating IP provisions of existing licensing/collaboration agreements which obviated what would have been an unnecessary multi-million dollar milestone payment and clarified ownership of new IP


Bob established Pharmidable Legal Advisors, LLC (formerly "Transpharmativ Legal Advisors, LLC") with former Cephalon colleague Randy Zakreski, Esq. to provide innovative consulting to small and large pharma and medical device/diagnostic companies.*


You can email Bob at rthrubiec@pharmidablelegal.com or rjzakreski@pharmidablelegal.com or call him at 1-484-667-6959.


Bob also provides IP services through a standalone company known as Innoventivip, LLC. For more information about these IP services Bob makes available, please visit www.innoventivip.com.


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