Hurley Consulting offers clients a broad range of consulting expertise together with comprehensive contract research services. Our services range from nonclinical assessments, clinical trial design, data analysis, regulatory strategy and submissions, to outcomes research, reimbursement strategies, and marketing assessments. We unite the strategy, planning, and analytical expertise needed for product development and/or evaluation of business opportunities.
Regulatory Affairs
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The development process is continuously evolving. Successful project support demands scientific expertise, industry experience, inherent flexibility, close attention to detail, and increasing technical requirements to produce electronic submissions.
We can work with the sponsor to prepare development plans to meet marketing objectives and regulatory requirements.
Using the sponsor's style guide and requirements for electronic submissions, we can prepare reports and summary documents in accordance with 21CFR, ICH and FDA guidelines and requirements.
We can compile, validate, and electronically submit documents to FDA through the Electronic Submission Gateway (ESG).
We can collaborate with the sponsor to review and evaluate data in the context of health authority regulatory requirements.
If requested, we can represent sponsors in regulatory negotiations and health authority meetings.
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Quality Assurance
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Product development and support for registered products requires a high standard of Quality Assurance and Compliance.
The preparation and review of documentation, verification, and auditing is essential for successful commercialization. In addition to performing independent Quality Assurance and auditing services for sponsors, we design and implement specialized training programs in these disciplines. Our internal educational activities extend to training in the general product development process and in regulatory affairs and compliance activities.
Document and
Documentation
Review, Verification & Auditing |
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Specialized Training in Product Development & Regulatory Affairs |
• Drug Supplies and Packaging
• Analytical Assay Procedures
• Protocol Compliance Assessments• Database Audits
• Regulatory Submissions
• GXP
• DEA Compliance Issues
• Site Audits |
• Drug Development Process
• FDA Advisory Committee Presentations• GMP, GLP, GCP Regulations
• Science and Technology
• FDA Negotiations
• Quality Assurance/Auditing |
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Project Evaluation & Development Plans
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A successful product development program begins with a comprehensive understanding of the project and the goals and objectives of the sponsor.
Whether the project is an internal development project or an in-licensing opportunity, decisions are based on a rigorous evaluation of the available data. Development of a strategy for execution, and identification of any additional information required, is a core competence at Hurley Consulting. Our expert multidisciplinary staff can design any additional studies required and provide the support needed to successfully complete the program.
| Due Diligence |
|
Development Plans |
• Product Portfolio Analysis
• Licensing and Acquisition Evaluations• Clinical Assessments
• Nonclinical Assessments
• Risk Benefit Analysis
• Safety Assessment |
• Identification of Key Success Factors• Profiling Strategies
• Positioning Strategies
• Regulatory Strategy
• Competitive Analysis |
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Study Design
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We provide support with the design of studies and identification of methods to efficiently measure, collect, and analyze nonclinical and clinical data.
• Protocol Design/Review
• Sample Size Determination
• Statistical Methodology
• Statistical Analysis Plan (SAP) Development paradigm
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Nonclinical Assessments &
Program Management
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We offer pharmacology and toxicology expertise using in house resources and senior staff experience.
Development requirements are continuously evolving and successful project support demands scientific expertise, industry experience, an inherent flexibility, and a close attention to detail.
We evaluate nonclinical data needs with respect to local health authority regulations, ICH guidelines, marketing/reimbursement goals, and specific regulatory agency requirements.
| Areas of Expertise |
|
Development Programs |
• Pharmacology
• Toxicology
• Pharmacokinetics/Toxicokinetics
• ADME
• In vitro/In vivo Metabolism
• Bioanalytical Laboratory Selection
and Oversight
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• Detailed Plans and Protocols,
• Safety Assessments |
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Legacy Project Evaluation and File Organization
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We offer complete analysis of legacy data, evaluation of database status according to current regulatory requirements, and strategic planning for database fulfillment.
Ensuring that information is current and appropriate is an important consideration to minimize product risk, especially in regard to legacy products, the acquisition or divestment of products, or to support U.S. registration. Potential product risks include recalls, out-of-stock situations, or regulatory sanctions, and can provide key data for commercial decision-making. The documentation of the review provides an administrative and legal record to support decisions; can identify problems and remedies; can serve as a reference guide for other reviewers; and, provides a concise technical information source for Regulatory Affairs, Quality Assurance and Quality Control and other disciplines as needed.
| CMC Information |
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Compliance Assessment |
• Manufacturing and Testing Facilities• Raw Materials, Purity, and Methods Validations &Specifications• Process Controls
• Container and Closure Systems
• Stability and Batch Data
• Outer Packaging Labels
• Environmental Considerations |
• Status of Legal/Regulatory
Actions for the Sponsor or the Subcontractors Referenced inthe Proposed Submission • Pending Compliance Issues
(e.g. 483s, Warning Letters, Establishment Inspections Reports, etc.) • CMC Documentation
Review/Change Control – Site Changes – Manufacturing Process (Active and Product) – Analytical Methods (Active and Product) – Test or Process Equipment • Outstanding Reports, Protocols Referred to in theDocuments |
| Regulatory Files and Correspondences Organization |
• Submissions
• Health Authority Correspondence
• Application Summaries
• Annotated Labeling |
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Pharmaceutical Technology
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We design or contribute to strategies for evaluating and transferring analytical and formulation technologies.
• Analytical Method Selection, Validation, and Transfer
• Formulation, Evaluation, and Selection
• Stability Program Design
• Design of Method and Process Validation Studies
• Manufacturing Process Transfer
• Process Operations Analysis
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Data Management
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We create study data tabulation model datasets (SDTM) and CDISC compliant analyses datasets (ADaM). We provide data entry, review, and presentation of trial data using a validated data management system with an electronic audit trail.
Our experienced programmers and statisticians are expert in performing data
integration, data management and statistical analysis services. All our services
are performed on validated data management systems with electronic audit trail.
Data can be taken at any stage in the process.
| Database Integration |
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Data Management |
• Prospective and Retrospective
Integrated Database Creation and Data Consolidation (“Meta Database”)• Adverse Event, Medical History,
and Concomitant Medication Coding Standardization Across Trials• Database Validation and
Documentation |
• CDISC Dataset Preparation and Validation• QA/QC Datasets
• Study Design Tailored Consistency Checks• Data Clean-up |
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Statistical Analysis
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We provide statistical analysis services in close cooperation with the sponsor.
• Statistical Analysis Plan Development
• Safety and Efficacy Analyses
• Data Interpretation and Reporting
• Recreation of SAS Programs for Legacy Projects
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Pharmacovigilance
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We help with timely reporting based on SOPs.
• Integration of Nonclinical and Clinical Results
• Expertise in Multiple Adverse Event and Concomitant
Medication Dictionaries • Early Identification of Trends
• Coding Review
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Electronic Compilation & Submission
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Our electronic compilation and submission processes encompass all steps from document preparation, processing, and organization, through publishing, QC and validation, submission to FDA, and life cycle management.
Our processes ensure these regulatory requirements are met:
• Organization and XML backbone using eCTD specifications for
global submissions • eCTD study tagging files
• Module 1 regional information
• Software version compatibility
• Bookmarking and hyperlinking
• Document granularity
• Document
- Font and margins- Page size, orientation, and numbering
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Properties, security, and indexing • File format, file name, and file size
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