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  Finding Solutions to your most difficult drug development challenges for 25 years.

Hurley Consulting Associates Ltd. is an international consulting company serving the health sciences industry since 1987.  With unique expertise to prepare datasets, reports, global regulatory submission documents and dossiers, Hurley Consulting integrates nonclinical, clinical, and manufacturing and control evaluations, performs data analyses and develops and implements regulatory strategies.

For over 25 years Hurley Consulting has supported clients for the entire IND through NDA process.  We are recognized within the health sciences industry for the high level of our expertise and the excellent quality of our work.

Hurley Consulting offers clients a broad range of consulting expertise together with comprehensive contract research services and submission services including eCTD and CDISC.  Our services range from nonclinical assessments, clinical trial design, data analysis, regulatory strategy and submissions to marketing assessments.

We unite the strategy, planning, and analytical expertise needed for product development and/or evaluation of business opportunities. 
  In The News  
Cynthia F. Caracta, MD Appointed Vice President of Clinical Operations  
Upcoming Events

September 29 - 30, 2014
Austin Convention Center
Austin, Texas

Recent Events  

June 15 - June 19, 2014
San Diego Convention Center
San Diego, CA

September 28 - October 2, 2013
Hynes Convention Center
Boston, MA

September 19-20, 2013
Contract Pharma's Contracting & Outsourcing Conference
Hyatt Regency
New Brunswick, NJ

June 23-27, 2013
Boston Convention and Exhibition Center
Boston, MA

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Representative Projects

Over the past 25 years, Hurley Consulting has:

• Performed the statistical analyses or confirmed the results for clinical trials 
• Prepared and compiled clinical trial reports
Integrated the datasets, standardized coding, and finalized datasets
for submissions
• Prepared and compiled complete INDs and contributed to other INDs
Prepared and compiled complete NDAs and contributed to other NDAs
Prepared and compiled over 35 FDA meeting requests and briefing books
• Performed due diligence support for acquisitions
• Acted as the US authorized representative or agent

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Therapeutic Experience

  Technical Expertise

• Anti-Microbials and Sepsis
• Anesthetics and Anesthesia
• Cardiovascular
• Dermatology
• Endocrine and Metabolism
• Gastrointestinal and Coagulation
• Drug Products
• Genitourinary
• Hormone Replacement Therapy
• In vivo Diagnostic Agents
• Neuropharmacology
• NSAIDS/Analgesics
• Oncology
• Ophthalmology
• Pulmonary and Allergy

Drug Metabolism
Chemistry, Manufacturing, and Controls
• Biometrics (Data Management, Programming, and Statistics)CDISC Preparation and Validation
Clinical Research and Drug Safety
Regulatory Quality Assurance
Technical/Medical Writing & Editing
Electronic Submissions (eCTD)

25 de forest avenue | summit, nj 07901 usa | phone: (908) 273-8490 | fax: (908) 273-2670 | solutions@hurleyconsulting.com