PRODUCT REGISTRATIONS
Streamlined Product Registration Solutions to Ensure Global Market Access and Regulatory Compliance
What We Offer
We offer comprehensive international product registration consulting services tailored to global regulatory standards. From documentation to approvals, we support medical devices, pharmaceuticals, biologics, and supplements. Our goal is to ensure compliance, reduce timelines, and enable successful global market access.
International Medical Device Product Registration Consulting Services
International medical device product registration consulting services support global market access through submissions like EU MDR/CE marking, FDA 510(k)/PMA, and registrations in markets such as Japan, Brazil, and China, including strategic planning and compliance with local requirements. We also manage document legalization processes, such as apostilles, embassy authentications, and country-specific certifications (e.g., CPP for some regions) to meet per-country regulatory demands for validity and acceptance.
International Pharmaceutical Product Registration Consulting Services
International pharmaceutical product registration consulting services facilitate drug approvals worldwide, handling NDA/MAA submissions to FDA, EMA, and authorities in Latin America, Asia, and Middle East, with expertise in dossier preparation and lifecycle management. Services include document legalization like notarizations, apostilles, consular legalizations, and Certificates of Pharmaceutical Product (CPP) tailored to each country's requirements for import and registration compliance.
International Biologics Product Registration Consulting Services
International biologics product registration consulting services aid in global approvals for biological products, including BLA/MAA submissions to FDA, EMA, and emerging markets in Asia, Africa, and GCC, focusing on CMC strategies and biosimilar pathways under ICH guidelines. We handle document legalization such as apostilles, embassy authentications, and specific certifications (e.g., GMP certificates) per country to ensure regulatory acceptance and smooth market entry.
International Supplements Product Registration Consulting Services
International supplements product registration consulting services assist with dietary supplement approvals globally, including FDA NDI notifications, EU novel food registrations, and compliance in markets like Asia and Latin America under varying regulations like DSHEA equivalents. Consulting encompasses document legalization, including apostilles, consular legalizations, and country-specific substantiation requirements for labels, ingredients, and safety data to meet import and registration standards.
Driving success through strategy
We specialize in helping small and mid-size businesses thrive by providing expert guidance in compliance planning and strategy.
Benefits: Why is it important for businesses?
ISO matters because it ensures your organization follows globally recognized standards for quality, safety, and efficiency. It builds trust, reduces risks, improves performance, and strengthens your ability to compete in global markets.ets.
Builds Trust & Credibility
Strong compliance and quality systems show customers, partners, and regulators that your business is reliable and committed to high standards.
Reduces Risk & Ensures Compliance
Clear processes help you avoid costly errors, audit failures, and regulatory penalties — protecting your operations and reputation.
Improves Efficiency & Performance
Standardized workflows reduce waste, streamline tasks, and enhance productivity across your organization.
Supports Growth & Market Expansion
Meeting recognized standards opens doors to new markets, global clients, and larger opportunities.
Next Steps
1. Schedule an Initial Consultation
Start by booking a call with our team. We’ll discuss your global product registration goals.
2. Submit Required Details
Based on your product classification and the countries where you would like to register, we will request that you share the necessary documents and company information. We will explain the steps and timelines for your registration.
3. Begin the Compliance Process
Our team will begin working with you step-by-step, to ensure the required documents are ready and legalization as needed depending on country requirements. We can provide Notary, Apostille and Authentication services.
4. Achieve Product Registration
With our expert guidance, your organization will progress smoothly through the registration process
Frequently Asked Questions
Find quick answers to the most common questions about our services and process.
Yes, our mobiles will come to your office and notarize all necessary documents
We can have your documents apostilled, and hand delivered back to you within 3 business days.
This time will vary based on the embassy it could be done immediately or there may be a 5-business day wait period.
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