Expertise

in Orphan Drug

WR Regulatory Services facilitates healthcare innovation with in-depth knowledge of Orphan Drug Designation from small molecules to cell and gene therapy products. WR assists clients with expert insights into orphan drugs and FDA guidelines on rare diseases.

OUR MISSION

Our Mission is to enhance the global advancement of the life sciences industry by bridging the continents
and providing regulatory guidance to set 
successful global footsteps
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US REGULATORY

AFFAIRS

Determine what regulations and requirements apply to your development project and tackle the regulatory challenges

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US AGENT

SERVICES

As the appointed US Agent for foreign firms, we represent your company in all dealings with the FDA

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EARLY STAGE

SUPPORT

Facilitate the early business development stage with our regulatory support by appointing us to be your “external employee”

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REGULATORY

DUE DILIGENCE

Perform regulatory due diligence for licensing, acquisition, investment decision with the expert

OUR SERVICES

Web Consultation
WR Regulatory Services leverages in-depth knowledge of the Europen, Asian, and US markets to provide cross-continental support for clients across the globe  
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OUR SPECIALTY

WR brings over 25 years of experience to our areas of excellence
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Pharmaceuticals

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Biologics

Advanced Therapies

FDA

ORPHAN DRUG

DESIGNATION

WR's team of experts has an in-depth knowledge of Orphan Drug Designation since 2007 with extensive experience in assisting clients and teaching workshops/seminars in the preparation and submission of requests for Orphan Drug Designation. The team has participated in successful designations of over 25 Orphan Drugs, including small molecules and cell and gene therapy products.