Your Trusted
Consulting Partner
Welcome to M.E. Dorat Consulting: Your Trusted Partner in Regulatory & Quality Compliance Excellence
Helping Businesses Stay Compliant at Every Stage of Growth
We believe that every regulation, no matter how intricate, can be made manageable and we were here to prove it.
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At M.E. Dorat Consulting - we stand as a beacon of expertise in the complex world of compliance. With over 25 years of hands-on experience, we specialize in guiding medical, biotech, and pharmaceutical companies through the intricacies of FDA, ISO, EU MDR, IVDR, and MDSAP standards. Our mission is simple: to bridge the gap between your current compliance challenges and your ambitious regulatory goals, transforming daunting regulations into achievable milestones.
We Always Put Your Interests First
In a field where precision is paramount, we differentiate ourselves through:
1.
Decades of Proven Regulatory Expertise
Over 25 years of experience guiding pharma, biotech, and medical device companies through complex FDA, EU MDR/IVDR, GxP, and ISO requirements.
2.
Tailored Compliance Solutions
No generic templates — we design strategies that fit your industry, product, and regulatory path, ensuring practical and sustainable compliance.
3.
End-to-End Compliance Support
From gap analysis and risk assessment to implementation, certification prep, and ongoing maintenance — we don't just advise; we partner.
4.
Experienced, Certified Auditors & Trainers
Our certified auditors and expert trainers don’t just advise — they audit your systems, train your team, and equip you with the practices needed for long-term compliance.
5.
Product Registration Services.
We provide quick apostille, notarization, and embassy attestation services — with convenient pick-up and delivery — so your documentation never delays your operations.
6.
Trusted Partner, Not Just a Consultant
We work as your long-term compliance partner, offering clear guidance, strategic insight, and scalable solutions that grow with your business.
Empowering with Expertise & Experience
Marie Dorat
CEO/Founder
Accomplished Regulatory and Quality leader with extensive experience in the Medical Device, Biotech, and Pharmaceutical industries. Proven ability to lead cross-functional teams, drive compliance initiatives, and manage complex projects in GCP and cGMP environments. Expert in clinical trial site preparation, regulatory submissions (BLA, IDE, 510k, IND, NDA), international product registrations, and quality systems development. Recognized strategic leadership, effective team collaboration, and delivering results on time and within budget. Strong command of ISO standards, FDA, ICH, EU MDR/IVDR, and MDSAP requirements, with a track record of guiding organizations through challenging compliance and consent decree situations.
Areas of Expertise:
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Leadership in Quality Systems Development
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Regulatory Strategy & Submissions
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Supplier Management & Program Leadership
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International Product Registration
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Team Management & Cross-Functional Collaboration
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QMS Remediation & Validation Oversight
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Crisis Management & Consent Decree Navigation
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Training, Mentorship & Staff Development
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ISO Lead Auditor (13485, 9001, 14001, 14971, 17025, 27001, 45001)
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Gap Analysis & Process Improvement
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Auditing Lead (GXP, FDA, GCP, ICH, GLP, cGM
Roy Bearry
Managing Compliance Partner
Quality Systems Leader with over 25 years of experience in compliance, process optimization, and audit readiness for medical devices, IVD, biologics, and pharmaceutical companies. Skilled in developing scalable Quality Management Systems (QMS), leading regulatory inspections, and implementing CAPA and supplier quality programs aligned with ISO, FDA, and international standards. Certified Lead Auditor with expertise in risk management, internal and supplier audits, and cross-functional collaboration supporting product launches and commercial operations.
Areas of Expertise:
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Quality Assurance & Regulatory Compliance
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CAPA & Nonconformance Management
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Supplier Quality & Risk Management
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Internal/External Auditing & Inspection Readiness
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Quality Training & Development
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Data Analysis & Interpretation
What Our Clients Say
5.0
Google Reviews
Kevin Lam
Completing the Quality Auditor Certification course was an incredibly rewarding experience. The program provided a comprehensive understanding of auditing priciples, ISO standards, and real-world quality management practices.
Marie and Roy were knowledgeable and supportive, making complex topics easy to grasp through practical workshops and case studies.
This certification not only strengthened my technical auditing skills but also boosted my confidence in supporting audits and contributing to organizational excellence. I highly recommend this course to anyone seeking to advance their career in quality management or continuous improvement.
Rockelle R.
Working with M.E. Dorat Consulting on our ISO 9001:2015 certification was an excellent experience. She brought deep QMS expertise, professionalism, and a genuine commitment to helping our team succeed. In addition, she is a pleasure to work with, and we will continue QMS improvement with her consulting services. I highly recommend her to any organization pursuing certification.
E. Waters
Thank you so much for your thorough and diligent work these past three days. I enjoyed myself, your material and your presentation skills. I learned a lot.
Vannessa K.
I found the ISO 13485 Lead Auditor Training class very informative. I know I'll able to audit with confidents. I love your training style.
Alex E.
The CAPA training class really provided clarity to the process - I learned a lot more than expected. I really thought I was a CAPA SME until I learned what I was missing from this session.
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25+ Years of Compliance Expertise You Can Trust.
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Los Angeles, CA
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