Industry Providers for Regulatory Services

Regulatory affairs

Arizona (Phoenix); Medelis, Inc.

California (Burlingame); PSI CRO

California (Costa Mesa); Promedica International

California (Manhattan Beach); CROMSOURCE

California (Oakland); Machaon Diagnostics, Thrombosis & Hemostasis Lab

California (Rolling Hills Estates); Criterium, Inc.

Florida (Miramar); Comprehensive Clinical Development

Illinois (Chicago); Excel Life Sciences

Illinois (Chicago); Radiant Development

Indiana (Indianapolis); Concentrics Research

Maryland (Baltimore); SNBL Clinical Pharmacology Center, Inc.

Maryland (Rockville); Accelovance

Maryland (Rockville); KAI Research, Inc.

Maryland (Rockville); Westat

Massachusetts (USA, Mexico, Colombia, Chile, Argentina); ESTERN Medical, LLC

Massachusetts (Cambridge); Outcome

Nebraska (Lincoln); Celerion

New Jersey (Bedminster); Integrium, LLC

New Jersey (Hackensack); Frontage Clinical Services (formerly ABR)

New Jersey (Hillsborough); PharmaTrials, Inc.

New Jersey (Princeton); Covance, Inc.

Updated New Jersey (Princeton); inVentiv Health Clinical

North Carolina (Durham); Novella Clinical

North Carolina (Raleigh); INC Research, Inc.

North Carolina (Wilmington); PPD, Inc.

North Carolina (Winston-Salem); PMG Research, Inc.

Ohio (Cincinnati); Imagepace

Ohio (Cincinnati); Medpace, Inc.

Ohio (Columbus); Remington-Davis Clinical Research

Pennsylvania (King of Prussia); Greenphire LLC

Pennsylvania (King of Prussia); Theorem Clinical Research

Pennsylvania (Philadelphia); Premier Research Group Ltd

Texas (Houston); Juno Clinical Research Services LLP

Texas (Houston); MedSource Consulting, Inc.

BRAZIL (São Paulo); EUROTRIALS SCIENTIFIC CONSULTANTS (BRAZIL)

Canada (Aurora, Ontario); IRB Services

Germany (80636 Munich); The Harrison Clinical Research Group

India (Andheri (East), Mumbai); ClinInvent Research Pvt Ltd

India (Noida - 201 301); Excel Life Sciences

Ireland (Dublin 2); Java Clinical Research ltd

Portugal (Lisboa); Eurotrials, Scientific Consultants

Document, manuscript and CANDA preparation

Arizona (Phoenix); Medelis, Inc.

California (Oakland); Machaon Diagnostics, Thrombosis & Hemostasis Lab

California (Rolling Hills Estates); Criterium, Inc.

Maryland (Rockville); Accelovance

Maryland (Rockville); KAI Research, Inc.

Maryland (Rockville); Westat

Nebraska (Lincoln); Celerion

New Jersey (Bedminster); Integrium, LLC

New Jersey (Hackensack); Frontage Clinical Services (formerly ABR)

New Jersey (Princeton); Covance, Inc.

Updated New Jersey (Princeton); inVentiv Health Clinical

North Carolina (Durham); Novella Clinical

North Carolina (Raleigh); INC Research, Inc.

North Carolina (Wilmington); PPD, Inc.

Ohio (Cincinnati); Medpace, Inc.

Oregon (Portland); Academic Network, a Stericycle Company

Pennsylvania (King of Prussia); Theorem Clinical Research

Pennsylvania (Philadelphia); Premier Research Group Ltd

Texas (Houston); MedSource Consulting, Inc.

Canada (Aurora, Ontario); IRB Services

Germany (80636 Munich); The Harrison Clinical Research Group

IND submission

Arizona (Phoenix); Medelis, Inc.

California (Oakland); Machaon Diagnostics, Thrombosis & Hemostasis Lab

California (Rolling Hills Estates); Criterium, Inc.

Illinois (Chicago); Excel Life Sciences

Maryland (Baltimore); SNBL Clinical Pharmacology Center, Inc.

Maryland (Rockville); Accelovance

Maryland (Rockville); KAI Research, Inc.

Maryland (Rockville); Westat

Massachusetts (USA, Mexico, Colombia, Chile, Argentina); ESTERN Medical, LLC

Nebraska (Lincoln); Celerion

New Jersey (Bedminster); Integrium, LLC

New Jersey (Hackensack); Frontage Clinical Services (formerly ABR)

New Jersey (Hillsborough); PharmaTrials, Inc.

New Jersey (Parsippany); DSP Clinical

New Jersey (Princeton); Covance, Inc.

Updated New Jersey (Princeton); inVentiv Health Clinical

North Carolina (Durham); Novella Clinical

North Carolina (Raleigh); INC Research, Inc.

North Carolina (Wilmington); PPD, Inc.

Ohio (Cincinnati); Medpace, Inc.

Pennsylvania (King of Prussia); Theorem Clinical Research

Pennsylvania (Philadelphia); Premier Research Group Ltd

Texas (Houston); Juno Clinical Research Services LLP

Texas (Houston); MedSource Consulting, Inc.

Germany (80636 Munich); The Harrison Clinical Research Group

India (Andheri (East), Mumbai); ClinInvent Research Pvt Ltd

India (Noida - 201 301); Excel Life Sciences

NDA submission

Arizona (Phoenix); Medelis, Inc.

California (Oakland); Machaon Diagnostics, Thrombosis & Hemostasis Lab

California (Rolling Hills Estates); Criterium, Inc.

Illinois (Chicago); Excel Life Sciences

Indiana (Indianapolis); Concentrics Research

Maryland (Rockville); Accelovance

Maryland (Rockville); KAI Research, Inc.

Maryland (Rockville); Westat

Massachusetts (USA, Mexico, Colombia, Chile, Argentina); ESTERN Medical, LLC

Nebraska (Lincoln); Celerion

New Jersey (Bedminster); Integrium, LLC

New Jersey (Hackensack); Frontage Clinical Services (formerly ABR)

New Jersey (Hillsborough); PharmaTrials, Inc.

New Jersey (Parsippany); DSP Clinical

New Jersey (Princeton); Covance, Inc.

Updated New Jersey (Princeton); inVentiv Health Clinical

North Carolina (Durham); Novella Clinical

North Carolina (Raleigh); INC Research, Inc.

North Carolina (Wilmington); PPD, Inc.

Ohio (Cincinnati); Imagepace

Ohio (Cincinnati); Medpace, Inc.

Pennsylvania (King of Prussia); Theorem Clinical Research

Pennsylvania (Philadelphia); Premier Research Group Ltd

Texas (Houston); Juno Clinical Research Services LLP

Texas (Houston); MedSource Consulting, Inc.

Germany (80636 Munich); The Harrison Clinical Research Group

India (Andheri (East), Mumbai); ClinInvent Research Pvt Ltd

India (Noida - 201 301); Excel Life Sciences

Regulatory consulting

Arizona (Phoenix); Medelis, Inc.

California (Burlingame); PSI CRO

California (Costa Mesa); Promedica International

California (Oakland); Machaon Diagnostics, Thrombosis & Hemostasis Lab

California (Rolling Hills Estates); Criterium, Inc.

Illinois (Chicago); Excel Life Sciences

Indiana (Indianapolis); Concentrics Research

Maryland (Rockville); Accelovance

Maryland (Rockville); KAI Research, Inc.

Maryland (Rockville); Westat

Massachusetts (USA, Mexico, Colombia, Chile, Argentina); ESTERN Medical, LLC

Nebraska (Lincoln); Celerion

New Jersey (Bedminster); Integrium, LLC

New Jersey (Hackensack); Frontage Clinical Services (formerly ABR)

New Jersey (Hillsborough); PharmaTrials, Inc.

New Jersey (Princeton); Covance, Inc.

Updated New Jersey (Princeton); inVentiv Health Clinical

New York (Tully); BioResearch Monitors, Inc.

North Carolina (Durham); Novella Clinical

North Carolina (Raleigh); INC Research, Inc.

North Carolina (Raleigh); Trio Clinical Research

North Carolina (Wilmington); PPD, Inc.

Ohio (Cincinnati); Imagepace

Ohio (Cincinnati); Medpace, Inc.

Ohio (Columbus); Remington-Davis Clinical Research

Oregon (Portland); Academic Network, a Stericycle Company

Pennsylvania (King of Prussia); Theorem Clinical Research

Pennsylvania (Philadelphia); Premier Research Group Ltd

Texas (Houston); Juno Clinical Research Services LLP

Texas (Houston); MedSource Consulting, Inc.

BRAZIL (São Paulo); EUROTRIALS SCIENTIFIC CONSULTANTS (BRAZIL)

Canada (Aurora, Ontario); IRB Services

Germany (80636 Munich); The Harrison Clinical Research Group

India (Noida - 201 301); Excel Life Sciences

Portugal (Lisboa); Eurotrials, Scientific Consultants