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.
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.
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.
Your company has been presented with a new opportunity—going public, acquiring a business, merging, or another new business relationship. We can help. Our team has the expertise to help you assess the risks and benefits of this potential endeavor.
HPM has deep experience in a wide variety of corporate and transactional matters as they relate to FDA, DEA, and USDA.