Hurley Consulting Associates

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.

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	Our proprietary regulatory and technical review tool used to perform gap analysis.

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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

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)