About Us

About Us

WE ARE THE TRUSTED EXPERTS

Our team of consultants brings decades of product development and regulatory consulting experience for pharmaceuticals, biologics and medical devices. We are dedicated to working closely with you through every stage of your product’s development process and help you bring your product to market in the most efficient manner.

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WE CAN:

Develop pragmatic approaches to regulatory challenges
Negotiate with the FDA and EU
Write, manage and review all modules of the CTD, IB, annual reports, and meeting packages
Prepare Orphan Drug Applications
Develop concise and thorough regulatory strategies

Strategically determine product placement
Utilize expedited regulatory pathways
Preform Due Diligence
Resolve complex pharmacology/toxicology, clinical or CMC issues
Serve as your US Agent
Prepare Integrated Development Plans
Publish your eCTD submission

OUR EXPERT TEAM USA

Dana Dunn, MS

President

Emilia Kostadinova

Vice President, Operations

Malia Segar, MS

Vice President, Regulatory Affairs

Andrew Bosco, MS

Vice President, Technical Regulatory Affairs

Mohit Kashyap, PhD

Senior Director, Regulatory Affairs

Mark Gehrke, PhD

Senior Consultant CMC

Cindy Roegge, PhD, DABT

Senior Nonclinical Consultant

Amy Robinson, PhD

Director, Regulatory Affairs

Spencer Kim, PhD

Medical Writer

Alexandria Szalanczy, PhD

Medical Writer

Kimberly Nye

Regulatory Associate

Anu Shrestha, MS

CMC Regulatory Associate

Saleha Ripa

Senior Regulatory Publisher, Team Lead

Donna Bell

Senior Regulatory Publisher

Suhasini Rao

Senior Regulatory Publisher

Rachel Cook

Rachel Cook

Senior Regulatory Publisher

OUR EXPERT TEAM EU