Anticipate and Mitigate Risk.
YourEncore established our Regulatory Center of Excellence to help clients successfully navigate the continuously evolving regulatory environment. We are veteran industry leaders who know what it takes to get products to market and successfully anticipate and mitigate risk. We understand the process. We bring unparalleled scientific knowledge and long-standing relationships. We work alongside clients helping you to understand what’s needed and deliver with excellence.
Develop the strategy, build the roadmap, and anticipate challenges to meet critical milestones with confidence.
Effectively advance your regulatory strategy with operational support when and where you need it.
Understand the potential impact of regulatory changes on your regulatory programs and business.
Get experienced counsel to ensure you have a voice when you need it.
Strategic regulatory counsel
At YourEncore, we are more than regulatory experts. We are former executives and practitioners. We are professionals with deep experience getting life changing products into the hands of consumers and patients. We are FDA veterans with long-standing relationships.
We have worked across all therapeutic areas and classifications including 505(b)(2)s, new chemical entities, orphan drugs, generics, combination products, and more. We know what it takes to advance the drug development process. We stand ready to help you deliver.
Former SVP, Regulatory Affairs at BMS
Joe Lamendola, over a 30 year regulatory career, has been responsible for 30+ approvals across 10+ therapeutic areas. With hundreds, if not thousands, of agency interactions under his belt, Joe provides clients with the insights, relationships, and credibility needed to bring drugs to patients quicker.Read More
Former Sr. Director of US Regulatory Affairs at Eli Lilly
Anne Marie Finley
Former VP of Government Regulations & Public Policy at Celgene
Former VP of US Regulatory Strategy at Pfizer
Former VP, Regulatory Affairs, Avillion