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  Finding Solutions to your most difficult drug development challenges for over 30 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 the last 30 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/for evaluation of business opportunities. 
 
  In The News  
Hurley Consulting Is Celebrating over 30 Years In Business!  
   
Upcoming Events

June 3–6, 2019
Pennsylvania Convention Center
Philadelphia, PA
Booth #4035

Recent Events  

February 11-13, 2019
RSIDM
Bethesda Marriott Hotel & Conference Center
Booth #206

   
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Representative Projects

Over the years, Hurley Consulting has:

• Provided strategic insight through scientific and regulatory review of programs
• Developed project plans from nonclinical through clinical development
• Designed and managed clinical trials
• Performed statistical analyses and confirmed results for clinical trials 
• Prepared and compiled clinical trial reports
Integrated datasets, standardized coding, and finalized datasets
for submissions
• Prepared and compiled INDs
Prepared and compiled NDAs
Prepared and compiled over 45 FDA meeting requests and briefing books
• Performed due diligence support for acquisitions
• Acted as a 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
• Genitourinary
• Hormone Replacement Therapy
• In vivo Diagnostic Agents
• Neuropharmacology
• NSAIDS/Analgesics
• Oncology
• Ophthalmology
• Pulmonary and Allergy
• Vaccines

Pharmacology
Toxicology/Toxicokinetics
Pharmacokinetics
Drug Metabolism
Chemistry, Manufacturing, and Controls
• Biometrics
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