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Hubbell Consulting, LLC

Description: 

Hubbell Consulting, LLC provides regulatory consulting, clinical trial management, and medical/regulatory writing services to the pharmaceutical, biotechnology, and medical device industries, and to contract research organizations worldwide.   We strive to apply our experience and expertise in research and development and in regulatory affairs to contribute to these industries and improve human health.   We emphasize quality, collaboration, commitment, communication, respect, and responsibility.   We focus on our clients' needs and priorities, adhering to agreed upon timelines and striving to uphold the values of accountability, confidentiality, expertise, excellence, integrity, and reliability.  

Since 1987, Hubbell Consulting has built a reputation of excellence in project execution and delivery.   The Hubbell Consulting team is comprised of individuals with many years of experience in scientific communications, clinical research and regulatory affairs.   Hubbell Consulting has extensive experience in Phases 1-4 of clinical development and in a large variety of therapeutic areas.   Services provided by Hubbell Consulting include the following:

Regulatory Affairs Consulting

Hubbell Consulting advises our clients to ensure that they fulfill regulatory, scientific and clinical requirements and comply with the laws and regulations required by worldwide regulatory agencies.   Our consultants work directly with regulatory agencies on our clients' behalf.   Hubbell Consulting has experience in the following areas:

  • Regulatory strategy development
  • IND and IDE submissions and maintenance (including Annual Reports)
  • GCP, GLP and GMP audits
  • Develop strategy and run Pre-IND, Pre-NDA meetings
  • Pre-IND, Pre-NDA briefing packages
  • Presentations to the FDA
  • Negotiations with FDA
  • Responses to FDA inspections (483s) and other FDA correspondence
  • 505(b)(2) strategy and NDA submissions
  • eCTD preparation: Module 2 (2.2, 2.4, 2.5, 2.6, 2.7) and Module 5 (ISE, ISS, 505(b)(2) summaries)
  • Due diligence for technology licensing
  • Toxicology package development

 Clinical Trial Management Services

Hubbell Consulting provides clinical trial management services, all performed under GCPs and in accordance with ICH guidelines and the Declaration of Helsinki.   These services include:

  • Clinical strategy development
  • Identification, audit, negotiation and selection of clinical sites, CROs, clinical laboratories and third party clinical supplies packaging sites
  • Preparation and submission of IRB/IEC documents
  • Designing CRFs (paper and electronic), diaries, and clinical study forms
  • Performance of site qualification, initiation, monitoring visits and close out visits
  • Writing study monitoring reports
  • Reviewing clinical data
  • Expediting data clarification and missing data resolution
  • Performance of day to day oversight of the clinical trial
  • Performance of due diligence for technology licensing

 Medical and Regulatory Writing Services

Hubbell Consulting provides a complete approach to medical and regulatory writing and can assist your company in the development, preparation, and review of documents in support of regulatory submissions and clinical trials, including:

  • Clinical Study Reports (CSRs)
  • Clinical protocols
  • Informed Consent Documents
  • Case Report Forms
  • Study Reference Manuals
  • Patient Diaries
  • Clinical Trial Registry documents
  • Safety Narratives
  • Clinical Evaluation Reports (CERs)
  • Investigator's Brochures (IBs)
  • Investigational New Drug (IND) Applications
  • IND Annual Reports
  • New Drug Applications (NDAs)
  • Drug Master Files (DMFs)
  • eCTDs (Module 2, Module 5)
  • 505(b)(2) Searches and Summaries
  • Marketing Applications
  • Orphan Drug Applications
  • Drug Establishment Registration
  • Standard Operating Procedures (SOPs)
  • Meeting reports
  • Manuscripts for publication

Services: 

Claims Support Studies/Safety and Efficacy Studies, Clinical R&D, Clinical Study Reports, Clinical Trial Design, Medical Writing, Protocol Development, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation, Trial Management

Contact Information: 

Hubbell Consulting, LLC
215 Fries Mill Road
Turnersville, NJ, 08012, USA
Phone : 8562326308
Fax : 8562326309
Internet : www.hubbell-consulting.com
Email : information@hubbell-consulting.com
Contact Person : Howard R. Hubbell, Ph.D.