You’ve spent years developing a game-changing product. Before you shake up the industry, you need to begin production in compliance with cGMPs. HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes.

learn about our Compliance practice

You’ve worked hard to bring your product to market and the journey has just begun. Realizing your return on investment requires a successful product launch and ongoing promotion while meeting your regulatory obligations. Not an easy task. We’ve been there and we’re here to help.

learn about our Product Development & Authorization practice

Let us help you envision your product lifecycle. We can help you execute your regulatory and lifecycle management strategies with the coordination, rhythm, and grace necessary for success. Large and small companies alike benefit from help along the way. HPM can guide you through the innumerable regulatory challenges you’ll encounter.

learn about our Product Development & Authorization practice

You find yourself the recipient of an indictment, complaint or a show cause order. Maybe you are compelled to take the offensive against a competitor’s unlawful practices or an agency’s arbitrary final action.

learn about our Enforcement & Litigation practice