M. E. Dorat Consulting - Regulatory/Quality & Mobile Notary/Apostille Services
Your Trusted Partner for Regulatory and Quality Compliance in Medical Device, IVD, Biotech, and Pharmaceutical Industries.
Full service Notary/Apostille/Authentication Services
We'll help you prep your documents for International Product Registration in 48 to 72 hours
Our
Story
Get to Know Us
At M. E. Dorat Consulting, we have 25+ years specialize in delivering tailored quality and compliance solutions to the Medical Device, In Vitro Diagnostics (IVD), Biotech, and Pharmaceutical industries. With our deep expertise and commitment to excellence, we help organizations navigate complex regulatory landscapes and achieve sustainable compliance
OUR SERVICES
Welcome to our Quality Management Services! We specialize in designing and implementing robust Quality Management Systems (QMS) tailored to your organization's unique needs, ensuring compliance with global standards. Our comprehensive Quality Compliance Evaluations assess and identify gaps in alignment with FDA, GCP, EU MDR, IVDR, and MDSAP regulations. From thorough quality audits to leading CAPA initiatives and providing customized training programs, we are here to enhance your quality processes and facilitate seamless market entry for your products.
QUALITY COMPLIANCE SERVICES
International Product Regulations: Facilitate seamless market entry by navigating international regulatory requirements for your products. Ensuring quick documentation legalization services cutting the process from 6-8 weeks to 48 hours!
Quality System Development: Design and implement robust Quality Management Systems (QMS) tailored to your organization’s needs, ensuring compliance with global standard
Quality Compliance Evaluations: Comprehensive assessments to identify gaps and ensure alignment with FDA, GCP, EU MDR, IVDR, and MDSAP regulations.
Quality Audits: Certified Lead Auditor will conduct thorough audits to verify compliance with FDA, GCP, EU MDR, IVDR, and MDSAP requirements, delivering actionable insights for improvement.
PROJECT MANAGEMENT SERVICES
CAPA Project Management:
Our Corrective and Preventive Action (CAPA) project management service ensures compliance with regulatory standards by systematically addressing nonconformities and potential risks in medical device, IVD, biotech, and pharmaceutical environments.
Validation Project Management
Our Validation project management service supports the validation of processes, equipment, and software in compliance with FDA, EMA, and ISO standards for medical devices, IVDs, biotech, and pharmaceuticals.
e-QMS Solution Selection:
Our electronic Quality Management System (e-QMS) solution selection service assists in identifying, evaluating, and implementing the optimal e-QMS platform for medical device, IVD, biotech, and pharmaceutical companies.
TRAINING SERVICES
Corrective and Preventive Action (CAPA) Training
Objective: Equip professionals in the medical device, IVD, biotech, and pharmaceutical industries with the knowledge and skills to effectively implement and manage Corrective and Preventive Action (CAPA) processes in compliance with regulatory standards.
Clinical Trial Site Inspection Preparedness
Objective: Equip clinical trial site staff in the medical device, IVD, biotech, and pharmaceutical industries with skills to excel during regulatory inspections (e.g., FDA, EMA).
Risk-Based Monitoring
Objective: Train professionals in risk-based monitoring (RBM) to optimize clinical trial oversight in medical device, IVD, biotech, and pharma settings.
Internal Auditing
Objective: Prepare quality professionals to conduct effective internal audits in medical device, IVD, biotech, and pharmaceutical organizations.
DOCUMENT LEGALIZATION SERVICES
Our mobile services save time, reduce stress, and provide a personalized document legalization at your convenience.
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MOBILE NOTARY SERVICES
Here’s how the process typically works:
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Booking: You schedule an appointment, either online, via phone.
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Traveling: The notary comes to your chosen location—your home, office, hospital, or any other agreed-upon place.
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Document Verification: The notary verifies your identity using government-issued photo identification (e.g., a driver’s license or passport) to ensure you're the person signing the document.
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Notarization: The notary stamps and signs the document, officially notarizing it.
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Payment: You pay for the service, a travel fee based on distance will be included on top of the standard notary fee.
Call for pricing and to schedule your appointment today!
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MOBILE APOSTILLE SERVICES
A fast and convenient way to get your important documents certified with an Apostille, ensuring they are recognized for legal use internationally. Here’s how it works:
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Pickup: We come directly to your location in Los Angeles, Orange County or San Diego County to collect your documents.
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Apostille Certification: We handle the entire process of obtaining the Apostille from the appropriate authorities, ensuring your documents are properly certified.
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Same-Day or Next-Day Return: Once the Apostille is obtained, we return your certified documents within one business day, ensuring quick turnaround times.
This service is perfect for legal documents, birth certificates, marriage licenses, business agreements, and more that require international recognition, for international product registration. Our reliable service saves you the hassle.
Call for Pricing: Contact us today for pricing and to schedule your pickup!
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EMBASSY AUTHENTICATION SERVICES
Document authentication is the process of authenticating or certifying a document to ensure its validity and acceptance in a foreign country. It involves verifying the authenticity of signatures, seals, and stamps on the document and confirming that it complies with the legal requirements of the destination country.
We will go to the appropriate Embassy /consulate to obtain the authentication for you. The processing time for document authentication can vary depending on several factors, including the country of authentication and the complexity of the document. Typically, it can take anywhere from a few days to several weeks. Expedited processing options may be available for an additional fee.
Call for Pricing: Contact us today for pricing and to schedule your pickup!
GET IN TOUCH
Get Professionals
Reach out to ME Dorat Consulting to discover how we can provide professional Regulatory/Quality Compliance, Project Management Consultants and Trainers or to expedite your international product registrations.
Our Document Legalization can be scheduled for pick-up and delivery for companies in San Diego, North County, Orange County, and Los Angeles within within 24/48-hours .
