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IGAVIA SCIENCE helps medical device, IVD & cosmetic companies with regulatory compliance, product approval, and market entry as well as support for other regulatory affairs needs, a wide range of engineering compliance services, quality management systems implementation and in-country regulatory representation.

FDA Registration Approval Services Desliza

Igavia Science — FDA Regulatory Consulting → Medical Devices · US Agent · 510(k) · Cosmetics · MoCRA · ANMAT · ANVISA

ASUNTOS REGULATORIOS

Dispositivos médicos & Diagnostico In vitro (IVD)

Igavia Science brings together experienced FDA regulatory affairs professionals specialized in medical devices, IVD, and cosmetics. Our team guides international companies through every step of the US regulatory process — from device classification and 510(k) submission to US Agent designation, Establishment Registration, and Device Listing.

We work across all device classes and categories, including IVD, orthopedic, dental, cardiovascular, and Software as a Medical Device (SaMD) — delivering tailored regulatory strategies that reduce risk and accelerate your path to market.

TENGO ALGUNAS PREGUNTAS

FDA Registration Approval for your business

why the FDA needs an approval registration

Cøsméticos | Etiquetado

The US is the world’s largest cosmetics market — and under (MoCRA) (Modernization of Cosmetics Regulation Act), international cosmetic companies now face new mandatory requirements: FDA US Agent designation, facility registration, and product listing.

Igavia Science provides full MoCRA compliance services, cosmetic label review, and ingredient compliance review to ensure your products meet FDA standards and avoid import detentions.

Our cosmetics services include:

FDA US Agent for Cosmetics
MoCRA Facility Registration & Product Listing
Label Review (21 CFR Part 701)
Ingredient Compliance Review

ME GUSTARÍA EMPEZAR

members doing an FDA Registration for their company

ASUNTOS REGULATORIOS

Cøsméticos | Regulaciones de etiquetado

Proper labeling is critical for cosmetic products entering the US market. Under (MoCRA) and the FD&C Act, labels must comply with strict FDA requirements, including ingredient listings, warnings, and net quantity declarations. Non-compliant labels are one of the leading causes of FDA import detentions. Igavia Science offers a complete cosmetic label review to ensure your products clear customs and reach consumers without delays.

making a contract for FDA registration approval, where the 2 parties sign the contract

Our FDA Regulatory Services Include:

Igavia Science goes beyond traditional regulatory consulting — combining FDA regulatory expertise with hands-on support for medical product development, testing, and validation. One partner for your full path to market.

FDA US Agent & Device Registration

FDA regulatory consulting for international medical device companies, including US Agent representation, 510(k) submissions, Establishment Registration, Device Listing, and UDI submission. We handle every FDA requirement so you can focus on your product.

Estrategia regulatoria basada en cada proyecto

Customized regulatory strategy and submission planning for FDA, ANMAT, and ANVISA — helping you anticipate milestones, manage timelines, and minimize regulatory risk.

Consultoría regulatoria completa

Complete FDA regulatory consulting for medical devices and cosmetics, including US Agent representation, 510(k) submissions, Establishment Registration, ANMAT (Argentina), and ANVISA (Brazil) registrations.

Academia de formación en dispositivos médicos

FDA Regulatory Training

Igavia Science offers specialized FDA regulatory training for medical device and cosmetic companies. Courses cover device classification, 510(k) requirements, Establishment Registration, quality management systems (ISO 13485), and MoCRA compliance. Available for private groups, customized by topic and duration. Training available in English and Spanish.

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Cosmetic Label Review & Ingredient Compliance

Under (MoCRA) and the FD&C Act, cosmetic companies are legally responsible for the safety of their products and ingredients. A non-compliant label is one of the leading causes of FDA import detentions and customs delays.

Igavia Science provides complete cosmetic label review and ingredient compliance review — evaluating each ingredient against FDA requirements, prohibited substance lists, and INCI naming standards. We also assist with FDA product listing and formulation amendments under MoCRA.

The line between a cosmetic claim and a drug claim can be subtle — and misclassification can trigger FDA enforcement actions. We ensure your labels and claims are fully compliant before your products reach the US market.

Medicina Natural & Farma

Igavia Science provides FDA regulatory support for nutraceutical and pharmaceutical companies bringing natural health products to the US market — including dietary supplements, functional foods, ingredients, and beverages. We guide you through FDA registration, labeling compliance, and clinical research requirements to ensure your products are safe, effective, and market-ready.

FDA Regulatory Experts Committed to Your Market Success

Igavia Science combines deep FDA regulatory expertise with a genuine commitment to human health and environmental impact. We provide end-to-end regulatory consulting for medical device, IVD, cosmetic, OTC, and natural health product companies worldwide — delivering tailored strategies that help get your products to market faster, more safely, and fully compliant.