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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  
Hurley Consulting Appoints Christine Yu, MD as Vice President Development, Clinical Operations  
   
Upcoming Events

November 5-8, 2017
ACT
Palm Springs, CA Convention Center
PLEASE VISIT REGCHECK AT BOOTH #335

Recent Events  

September 9-12, 2017
RAPS
Gaylord National Resort and Convention Center
Oxon Hill, MD

March 12-16, 2017
SOT
Baltimore Convention Center
Baltimore, MD

February 6-8, 2017
Regulatory Submissions, Information, & Document Management Forum(RSIDM)
Bethesda North Marriott Hotel & Conference Center

   
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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 45 FDA meeting requests and briefing books
• Performed due diligence support for acquisitions
• Acted as the US authorized representative or agent

Read More

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

Pharmacology
Toxicology/Toxicokinetics
Pharmacokinetics
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