Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.
Greenleaf Health provided strategic and tactical advice to an early-stage start-up regarding their premarket submissions for a novel wound retraction system after the FDA determined that the company would need to follow the de novo pathway. The Greenleaf team assisted the company with development and submission of a de novo classification request for their product. …
Greenleaf Health worked with a multinational medical device company throughout the review and submission of a breakthrough device designation request for a device indicated for the minimally invasive treatment of lung tumors. The Greenleaf team provided strategic advice on how to frame the device description and indication for the breakthrough request in light of the …
Greenleaf Health worked with a multinational biopharmaceutical manufacturer to reinitiate their phase 3 program for a women’s health product, which had stalled after the FDA had voiced concerns with the design of the pivotal trial. The client needed a way to fulfill the Agency’s request for additional long-term outcomes data, which would require an expansion …
Greenleaf Health assisted a mid-sized pharmaceutical company in developing a regulatory strategy to address safety and trial conduct issues in the phase 3 program for their lead compound for cardiovascular disease. During phase 3 trials, the client identified a consequential safety event and sought Greenleaf’s guidance on both addressing the safety event in the context …
Upon receiving a Complete Response Letter (CRL) for their lead product to manage mild to moderate pain, a mid-sized specialty pharmaceutical company engaged Greenleaf Health to assist them in addressing the deficiencies cited in the CRL and developing a strategy for resubmitting the new drug application (NDA). Greenleaf’s regulatory experts, in conjunction with a partner …
