Hurley Consulting Associates

Finding Solutions to your most difficult drug development challenges for 22 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 22 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
	October 27, 2010 Regulatory Affairs Professionals Society Honors Hurley and Mondabaugh as 2010 RAPS Fellows
	Read More.





	Meet us
	March 6-10, 2011 SOT 50th Annual Conference & Exhibition Walter E. Washington Convention Center Washington, DC
	Read More.
	June 19-23, 2011 DIA 47th Annual Conference & Exhibition McCormick Place Chicago, IL
	Read More.
	October 20-22, 2011 AMWA's 71st Annual Conference The Hyatt Regency Jacksonville, FL
	Read More.
	October 23-26, 2011 RAPS 35th Annual Conference & Exhibition Indianapolis Convention Center Indianapolis, IN
	Read More.

	contact us

Representative Projects

Over the past 22 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

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)