NEB Pharmaceutical Consulting, LLC
NEB Pharmaceutical Consulting, LLC
More

Welcome to NEB Pharmaceutical Consulting, LLC

Welcome to NEB Pharmaceutical Consulting, LLCWelcome to NEB Pharmaceutical Consulting, LLCWelcome to NEB Pharmaceutical Consulting, LLC
Get in Touch

About

Nora is a Quality and Compliance Professional with more than 20 years of experience from the nations’ leading biotechnology, medical device, and pharmaceutical organizations including Biogen and Stryker Corporation. She has been called upon to manage the quality and compliance for companies at the forefront of discovery and development of novel cancer drugs and small-molecule medicines to fight difficult-to-treat cancers. Her reputation for excellence is the result of her extensive experience in GxP Quality Management Systems, QC processes for clinical study document management, and globalization procedures in the life science industries. She has exhaustive knowledge of international clinical stage readiness regulations and the rigors of filing readiness for the U.S. FDA, the European Union EMA, Japan’s PMDA, and Health Canada.

Nora has built her career working in a wide range of highly specialized departments including Pre-Clinical, Bio-Assay Development, Clinical Pharmacology, Medical Writing, Quality Assurance, and Regulatory Affairs- CMC. She is experienced in leading training programs and ensuring compliance, Post-Marketing Manufacturing Change Control Management, and leading the QC for international Board of Health queries. She is a strong leader committed to the work and brings integrity, organizational skills, and a spirit of collaboration to every task.

Contact us to see how NEB Pharmaceutical Consulting can help your company achieve quality excellence.

Services

Quality Management Systems Support/Auditing (GxP)

Quality Management Systems Support/Auditing (GxP)

Quality Management Systems Support/Auditing (GxP)

  • Manage Auditing Schedule and status for all GxP activities (ie, plan and coordinate audits)
  • Change Control Management – support globalization of procedures
  • Create (Global) Personnel Training Plans
  • Author/Draft Standard Operating Procedures (SOPs), Company Policies, Work Instructions, and supplemental forms (ie, Templates/Forms)
  • Ensure inspect

  • Manage Auditing Schedule and status for all GxP activities (ie, plan and coordinate audits)
  • Change Control Management – support globalization of procedures
  • Create (Global) Personnel Training Plans
  • Author/Draft Standard Operating Procedures (SOPs), Company Policies, Work Instructions, and supplemental forms (ie, Templates/Forms)
  • Ensure inspection readiness (documents up to date, preparation efforts for audits/inspections)

Auditing

  • Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), and non-GLP (CRO pre-qualification audit)
  • Ensure Quality of Reports for Validated Systems (software) and Validated Instrumentation to support laboratory Procedures



Document Quality Control (QC)/ Medical Writing

Quality Management Systems Support/Auditing (GxP)

Quality Management Systems Support/Auditing (GxP)


  • Quality Review of supporting Documentation intended to be submitted to regulatory agencies for drug approval including: Investigational New Drug, Protocols, Informed Consent Forms, Clinical Study Reports, Biologics License Application, New Drug Application, Investigational Brochure, Briefing Book, Regulatory Responses, and Product Labelin


  • Quality Review of supporting Documentation intended to be submitted to regulatory agencies for drug approval including: Investigational New Drug, Protocols, Informed Consent Forms, Clinical Study Reports, Biologics License Application, New Drug Application, Investigational Brochure, Briefing Book, Regulatory Responses, and Product Labeling.


Medical Writing Support

  • Draft Safety Patient Narratives using Council for International Organizations of Medical Sciences (CIOMS [Clinical Study Pharmacovigilance Notes])
  • Formatting and editing support/ document QC as described above

Clinical Operations and Training Courses

Quality Management Systems Support/Auditing (GxP)

Clinical Operations and Training Courses

  • Implementation of GCP SOPs
  • Risk Management and Strategy
  • Process Improvement
  • Quality Agreements and Plans
  • Issue Management and Vendor Oversight


Training Courses

  • Good Clinical Practices (GCP)
  • Good Documentation Practices (GDP)
  • Good Laboratory Practices (GLP)
  • Good Manufacturing Practices (GMP)
  • GxPs Overview 
    • (Includes GCP, GDP, GLP, and GMP)

Contact Us

Drop us a line!

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Location

NEB Pharmaceutical Consulting is located in the MetroWest Boston area, but we can support clients and their projects globally. Contact us to see how NEB Pharmaceutical Consulting can guide your company to achieve quality excellence.

NEB Pharmaceutical Consulting, LLC

P.O. Box 5102, Framingham, Massachusetts, United States

Info@NEBPharma.com

Hours

Standard USA Business Hours (EST) with International Flexibility

Social

Copyright © 2022 NEB Pharmaceutical Consulting, LLC - All Rights Reserved.

This website uses cookies.

We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.

Accept