Strategic Regulatory Issues

Pharmaceutical Law Group advises leading U.S. pharmaceutical and biotechnology manufacturers, research and drug development companies, and investors on FDA regulatory matters.

As a registered patent attorney and non-practicing physician, Gregory Glover assists pharmaceutical biotechnology companies in compliance with FDA policies and regulations related to drug and device research and development, FDA approval matters, and competitor market entry. Dr. Glover also offers pharmaceutical and biotech companies, manufacturers, and drug sponsors a variety of valuable regulatory strategy services across the product life cycle.

Product Approval Strategies

Competitive success in pharmaceutical research and drug development relies upon skilled and strategic navigation of a complex array of policies and regulations enforced by the FDA. FDA approval for drug products, biologics, and medical devices requires expert insight on approaches to maximize market incentives and intellectual property protection in compliance with FDA regulations. Pharmaceutical Law Group counsels biotechnology and pharmaceutical investigators, manufacturers, life sciences companies, and other FDA-regulated entities on life cycle strategy matters, including the regulatory implications of market exclusivity provisions, specialized regulatory incentives, treatment protocols, novel drugs, combination products, approval provisions, expedited review paths, and emerging issues relating to companion diagnostics and personalized medicine.

Competitor Market Entry

Understanding the opportunities for competitor market entry requires unique insight into FDA regulation and guidances, including matters involving market exclusivity analyses, product labeling, Orange Book listings, patent use codes, legislative proposal implications, post-approval manufacturing practices.

Pharmaceutical Law Group specializes in the strategic application of market exclusivity opportunities arising from the Hatch-Waxman Act, Orphan Drug Act, pediatric exclusivity, and the Biologics Price Competition and Innovation Act (BCPIA).

Regulatory Strategy Services

Pharmaceutical Law Group offers a variety of regulatory strategy services, including counsel on:

  • Life cycle management, industry guidances, product labeling, exclusivity provisions, risk management, regulatory enforcement actions;
  • NDA, ANDA, and 505(b)(2) submissions, Hatch-Waxman and BPCIA, market exclusivity options, orphan drug designation, breakthrough therapy, fast track, accelerated approval pathways;
  • Due diligence review of life cycle management strategies; and
  • Adversarial proceedings relating to licensing agreements, contracts, and patent infringement.

Pharma Regulatory Expertise

Pharmaceutical Law Group makes every effort to help clients secure prompt marketing approval of their products, to maintain the lawful status of products in the marketplace, to foster helpful governmental regulatory policies, and to assist our clients in competing in the marketplace to the full extent permitted by regulations and applicable law.

Dr. Gregory Glover advises pharmaceutical and biotechnology companies on a wide range of strategic Regulatory IP matters such as FDA regulatory exclusivity, regulatory incentives, strategic product development, and lifecycle management.

To Connect with Gregory Glover and Pharmaceutical Law Group

Contact Pharmaceutical Law Group at 202.589.1780 or by EMAIL