プロフィール詳細

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Irina B.に依頼

Ireland

Pharma & Medical Device HPRA & EU Regulatory Affairs Expert | WDA/GDP Compliance | QP/RP Services – 15+ Years Experience

プロフィール概要

QA compliance, Regulatory Affairs, FDA, MHRA, UKCA/ UK Conformity Assessment (for medical devices post-Brexit) HPRA, WDA, EU medical devices, pharma regulatory, QP/RP expert I am a senior Regulatory Affairs and Quality Assurance professional with 15+ years of experience in the EU healthcare industry, specialising in HPRA approvals, WDA submissions, GDP compliance, and QP/RP services. I have successfully led numerous projects for pharmaceutical manufacturers, wholesalers, and medical device companies, ensuring full compliance with EU and Irish regulatory frameworks. My services include regulatory strategy, gap analysis, SOP development, audit readiness, and dossier preparation for licensing. Clients benefit from my in-depth knowledge of HPRA processes, my proven track record of delivering approvals on time, and my commitment to quality at every stage. I work with strict confidentiality and deliverables backed by clear timelines and milestone-based payment structures. I provide expert Quality Assurance (QA) and Regulatory Affairs support for pharmaceutical and medical device companies. With over 15 years of experience as a QP/RP, I specialize in preparing submission-ready dossiers, ensuring compliance with EU regulations (HPRA, WDA), and guiding companies through fast-track approvals. I help clients save time, reduce compliance risks, and secure approvals efficiently. With 15+ years of experience in Quality Assurance, Regulatory Affairs, and QP/RP roles in the pharmaceutical and medical device industries, I provide fast, accurate, and fully compliant regulatory solutions for EU and international clients. I specialize in: - HPRA/WDA submissions and approvals in Ireland and EU markets - Full QA/Regulatory compliance audits and checklists, -Regulatory submissions documentation for pharmaceuticals and medical devices - CV and cover letter optimization for pharma/regulatory roles - Medical device documentation and regulatory strategy consulting -QA system audits, SOP reviews, and corrective action plans -Preparation of checklists and templates to ensure regulatory approval readiness FDA clinical trial submissions -eCTD formatting expertise -21 CFR Part 11/Part 312/Part 314 experience -UK MHRA & EU regulatory experience -Pharmaceutical & medical device regulatory projects I deliver high-value projects efficiently, with ready-to-use packages and clear guidance to ensure regulatory compliance. Typical project delivery: 5–10 hours. My hourly rate: $400, reflecting premium expertise and rapid, accurate results. Clients benefit from my 15+ years in regulatory affairs and quality assurance leading to faster approvals, streamlined submissions, and practical compliance solutions.

専門分野

• ☆ Drug Development
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Healthcare Administration & Management
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance
• ☆ Gap Analysis
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ CMC Documentation
• ☆ Nonclinical Study Documentation
• ☆ Investigational New Drug (IND) Application Writing

サービス

• Writing
• Product Development

Writing Non-Medical Regulatory Writing

Product Development Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Seniour Consultant EU RP/QP Quality Assurance and Regulatory Affairs Pharmaceuticals/Medical Device

Independent Consultant (Freelance expert)

1月 2008 - 現在

学歴

MSc. Oncology Research and experimemtal design

National University Of Ireland

5月 2010 - 9月 2011

Degree Applied Bio-Biopharmaceutical and Healthcare Science

Galway Mayo Institute of Technology - Ireland

5月 2005 - 6月 2009

認定資格

• GDP Compliance Certification QP Qualification ISO 13485 Internal Auditor GxP Training Certification

  GMIT

  1月 2025 - 現在