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


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

Full-service programs

Targeted objectives

Due diligence

Read More

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


Advertising & promotion

Strategic regulatory counsel

Monitoring and surveillance

Read More

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

Read More

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.


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.

Read More


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

Steve Pondell
Former VP CMC & Operations at ImmunoMet Therapeutics

A Partner You Can Count On

Copyright © 2020 YourEncore. All rights reserved. Trust Center.