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ABOUT ME Regulatory documentation either moves your filing forward or it doesn't. I make sure it does. I'm a RAC-Drugs certified Regulatory Affairs consultant with 4+ years of hands-on experience supporting pharma, biotech, and medtech teams across FDA, EMA, Health Canada, CDSCO, and ICH frameworks. I deliver submission-ready documentation — not drafts that need rework. Most regulatory documents fail not because of bad science, but because they're poorly structured, inconsistently formatted, or not written to how reviewers actually think. That's the gap I close. What I Deliver: — IND/CTA and NDA/ANDA module drafting (Modules 2–5) — eCTD structure, publishing, and sequence preparation — Clinical writing: Protocols, IBs, CSRs, safety summaries — Labeling: USPI, SmPC, CCDS review and compliance — Regulatory gap analysis and audit readiness — SOPs, QA systems, CAPA documentation — Health Canada submissions and compliance strategy — MDR/IVDR: CERs, PERs, and technical file support Why Clients Choose Me: — RAC-Drugs certified — validated expertise, not self-declared — Top Rated Plus with 100% Job Success Score across all engagements — Structured, defensible documentation delivered on timeline — Direct, senior-level execution — no juniors, no handoffs — Built for lean teams and tight regulatory deadlines If your regulatory documentation needs to be submission-ready — not just technically complete — send me your project brief. I respond within hours and I don't deliver work that needs rework.

PROFESSIONAL SUMMARY With over two decades in the medical device sector, I am a seasoned Senior Medical Device Consultant offering comprehensive expertise in global marketing authorization, EU MDR compliance, and robust quality management systems. My specialization lies in ensuring medical device product compliance, spearheading both internal and external audits, implementing advanced risk management strategies, and guiding post-market procedures. My proficiency extends to the design and management of Unique Device Identifications (UDIs), and I possess a deep understanding of Software as a Medical Device (SaMD). Having hands-on experience with a spectrum of international regulatory frameworks, I am adept with guidelines from the FDA, EU MDR, MDSAP, MHRA, PMDA, JPAL, TGA, and ANVISA. My extensive knowledge also covers critical areas like distribution selection and liaison with local competent authorities. This ensures that the products not only meet global standards but also align with regional and local compliance requirements. In my consulting capacity, I've consistently been the trusted advisor to senior and executive management teams of my clientele. I provide strategic direction, clarity on compliance obligations, and navigate the ever-evolving landscape of medical device regulations. Furthermore, I offer companies' executive teams pointed direction on imperative action items and provide invaluable insights on managing relationships with distribution networks and local regulatory bodies. PROFESSIONAL SERIVCES 1. Global Marketing Authorization 2. Regulatory Compliance 3. Quality Management Systems (QMS) 4. Post-Market Surveillance (PMS) 5. UDIs Management 6. Clinical Evaluation 7. International Council for Harmonisation (ICH) 8. Medical Device Software (MDSW) & Software as a Medical Device (SaMD) 9. Data Protection Impact Assessment (DPIA) EDUCATION • BSI, AU - Management Systems Auditing, 2018 • BSI, ISO 13485:2016 Internal Auditor (TPECS), 2018 • BSI, MD - Medical Devices Quality Management Systems, 2018 • American Society for Quality, ASQ-Certified Six Sigma Green Belt, 2008 • Mohawk College, Mechanical Engineering, 2001-2004

I help biotech startups, pharmaceutical companies, and research sites navigate the complexities of clinical trial operations, regulatory compliance, and site management. With experience in both the hospital research setting and the pharmaceutical industry, I specialize in regulatory documentation, IRB submissions, and end-to-end clinical trial execution. From study startup to closeout, I ensure compliance with FDA and ICH-GCP regulations, facilitate seamless collaboration between sponsors and sites, and optimize workflows to keep trials on track. As an independent consultant, I provide high-level regulatory and clinical trial support without the overhead of a full-time team, helping sponsors and sites streamline processes, maintain compliance, and successfully execute clinical trials from initiation to completion. SERVICES I OFFER REGULATORY & IRB SUBMISSIONS ✔️ Preparation and management of IRB submissions, protocol amendments, and informed consent forms ✔️ Regulatory document management and compliance oversight for clinical trials ✔️ Good Clinical Practice (GCP) compliance training and regulatory support for investigators and research teams CLINICAL TRIAL MANAGEMENT & OPERATIONS ✔️ Oversight of clinical trial activities from startup to closeout, ensuring compliance with regulatory requirements ✔️ Coordination of site regulatory documentation, essential document tracking, and audit readiness ✔️ Study feasibility assessments, site selection, and ongoing trial monitoring support FDA SUBMISSION SUPPORT & COMPLIANCE ✔️ Support for IND, IDE, and Pre-IND submission document preparation and review ✔️ Regulatory compliance consulting for FDA, ICH-GCP, and 21 CFR Part 11 requirements ✔️ Coordination of regulatory correspondence and submission strategy for clinical development programs DATA MANAGEMENT & MEDICAL WRITING ✔️ Case Report Form (CRF) development and electronic data capture (EDC) system support ✔️ Medical writing for clinical study documents, including protocols, investigator brochures, and study reports ✔️ Adverse event (AE/SAE) reporting support and regulatory compliance guidance 🔍 SKILLS & SERVICES Clinical Research, Clinical Trial Management, Regulatory Consultant, IRB Submission, FDA Submission Support, GCP Compliance, Site Regulatory Oversight, Clinical Trial Operations, Clinical Study Document Review, Investigator Training, Research Compliance, IND/IDE Submissions, 21 CFR Compliance, Medical Writing, Adverse Event Reporting, Study Feasibility, Site Selection, Audit Readiness Let’s connect! If you need expert support in clinical trial execution, regulatory compliance, or FDA submissions, I would love to hear from you.

A pharmacist with over 6years experience in healthcare and pharmaceutical industry. Invested in carrying out research and in-depth analysis to provide evidence and insights that feeds healthcare decisions, pharma business output and regulatory decisions. Particularly skilled in secondary research on medical literature databases, clinical trial research, systematic literature reviews, medical writing, pharmacovigilance reports and project management. Over 5 years experience in medical writing: SLR reports, Clinical Evaluation Reports, Global value dossiers, manuscripts, HTA reports and clinical summaries. I am very efficient, organized and result oriented. I pay adequate attention to all my projects so deliverables are developed excellently and completed in a timely manner thanks to my years of research, medical writing and project management. Feel free to contact me if you require my services. I look forward to working with you.

Are you navigating the complexities of regulatory compliance for health products, cosmetics, medical devices, or food in North America? With over 23 years of hands-on experience and in-depth knowledge, I am here to assist you with all your regulatory needs. What I Offer: 🔹 US Agent Services I provide comprehensive representation for foreign manufacturers, ensuring all FDA and Health Canada requirements are met. 🔹 Label Compliance Whether you need assistance with FDA or Health Canada labeling standards, I will ensure your products meet all regulatory requirements. 🔹 Cosmetic Notification (Health Canada) & MOCRA (US FDA) I facilitate smooth and compliant registrations, ensuring timely approvals and reducing delays. 🔹 Medical Device Submissions (Health Canada) & 510(k) Submissions (US FDA) From premarket notification to licensing, I guide you through the complex regulatory pathways for your medical devices. 🔹 Food Establishment Registration (US and Canada) I manage the entire registration process for food establishments, ensuring compliance with US FDA and Health Canada. 🔹 DIN & NHP Submissions (Health Canada) I have extensive experience preparing and submitting Drug Identification Numbers (DINs) and Natural Health Product (NHP) applications. 🔹 Site Licensing & GMP Certification (Health Canada) I handle site license applications and provide GMP certification support for manufacturers, ensuring they meet all Health Canada standards. 🔹 SOP Review & Writing I review and draft Standard Operating Procedures (SOPs) tailored to your operational needs, ensuring regulatory compliance and efficiency. 🔹 MDSAP & ISO 13485:2016 Certification I assist companies in obtaining MDSAP and ISO 13485:2016 certifications, ensuring their medical devices meet international quality standards. 🔹 HACCP/Food Safety Plans & PCP Plans I develop and implement effective Hazard Analysis Critical Control Points (HACCP) and Preventive Control Plans (PCP) for food safety compliance. Urgent Compliance Needs? I specialize in handling urgent compliance matters, helping you avoid penalties and regulatory delays. Why Work With Me? With a BSc in Pharmacy, an MBA, and being a Certified Regulatory Affairs Professional (RAP), I have the knowledge and experience to navigate the strict regulatory environments of both the U.S. and Canada. My services ensure that your products meet all the necessary requirements to enter and remain in the market successfully. Let’s Get Started! Contact me today to discuss how I can help streamline your regulatory processes and get your products to market faster.

I am a Certified Quality Auditor (CQA) with 7+ years of Quality & Regulatory Affairs work experience in the Medical Device, Pharmaceutical & Healthcare sectors. My main areas of focus are Regulatory Compliance and Standards, Quality Management Systems (QMS), Auditing, Document Review, Licensing and Post-Market Surveillance. I also possess expert knowledge in a handful of regulations including ISO 13485, ISO 9001, European MDR/MDD, FDA, Health Canada and MDSAP. Some of my other areas of expertise include technical writing of SOPs, quality forms, templates and work instructions as well as a proven track record of helping companies achieving Quality Management System compliance with ISO and other regulations. 📗 I'm always open to job offers, so please reach out to me and let me help you!