Setting the
Regulatory Standard

Advance Approvals.
Anticipate and Mitigate Risk.

Achieve Your Drug & Device
Development Goals.

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.


Proven Solutions

Strategic
Development

Develop the strategy, build the roadmap, and anticipate challenges to meet critical milestones with confidence.

Full-service programs


Targeted objectives


Due diligence


And more

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Submissions &
Regulatory Operations

Effectively advance your regulatory strategy with operational support when and where you need it.

Meeting preparation


IND, BLA, NDA applications


Briefing packet development


Medical writing/CMC documentation


Project management


Labeling


Advertising & promotion


Strategic regulatory counsel


Monitoring and surveillance


And more

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Regulatory Policy
& Intelligence

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


Monitoring and surveillance


Organization assessments


Education and training


And more

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Let Our Experience Be Your Advantage

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.

PRINCIPAL, REGULATORY CoE

Joe Lamendola
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.

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SENIOR REGULATORY EXPERTS

Norma Ascroft
Former Sr. Director of US Regulatory Affairs at Eli Lilly

Anne Marie Finley
Former VP of Government Regulations & Public Policy at Celgene

Brian Harvey
Former VP of US Regulatory Strategy at Pfizer

Graham Higson
Former VP, Regulatory Affairs, Avillion


A Partner You Can Count On

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