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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.
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REGULATORY AFFAIRS
Medical Devices & IVD
iGAVIA Science has certified regulatory affairs professionals that have years of experience working with the FDA throughout the diagnostics, biologics, and medical device industries. Why hire one FDA 510k consultant when you can have a group of savvy FDA 510k consultants that will carefully consider all strategies and alternatives during each step of the regulatory process
iGAVIA Science Group has expertise with a wide range of medical devices across all classes. Medical devices are increasingly more challenging from a regulatory perspective
Cøsmetics | Labelling
The United States of America is perceived as the largest market for cosmetics in terms of revenue. Cosmetic products in the USA are regulated by the Federal Food, Drug & Cosmetics Act (FD&C Act) and neither the products nor their ingredients are inspected by the Food and Drug Administration (FDA).
Claims for a product’s function must be thoroughly reviewed because, for example, skin protectants (such as diaper ointments), antiperspirants, treatments for dandruff or acne mouthwashes marketed with therapeutic claims, are classified as drugs thus losing the ground to market them as cosmetics.
Advantages
– End-to-end cosmetic Regulatory consultation
– Structured and cost-effective approach to ensure speed to market for the cosmetic products
REGULATORY AFFAIRS
Cøsmetics | Labelling Regulations
Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).
Our Expertise Includes:
iGAVIA goes beyond traditional regulatory consulting giving you the extra advantage of a product engineering team that also assists in medical product development, testing, strategic business resourcing and Product Design.
FDA Consulting
FDA Registration Approval consulting for compliance services that includes 510(k) approval process, Analysis, Testing, Establishment registration, U.S. Agent , Assistance in Device Listing, Medical Device Registration Renewal, UDI submission and engineering compliance.
Project-Based Regulatory Strategy
Project-based regulatory strategy and submission to help you plan your regulatory milestones and possible challenges.
Complete Regulatory Consulting
Complete regulatory consulting services for USA FDA, Mexico COFEPRIS, Argentina ANMAT, Brazil ANVISA, Ecuador ARCSA, Panama MINSA and Colombia INVIMA product approval submissions.
Medical Device Training Academy
Online Training Institute
Audience
The Medical Device Training Institute is directed to those working in the medical device industry. The curriculum provided is unique and not completely found in advanced biomedical engineering or regulatory affairs courses at the college level. A great deal of managers, quality engineers, and product development engineers and scientists are not formally trained in medical device regulations, quality management systems and/or product compliance issues. This can cause product delays, lack of compliance, and resources not effectively used in the product development or manufacturing processes. The training is aimed to provide introductory, high-level or advanced knowledge in key areas to those who are regularly involved in the medical device development, manufacturing or distribution industries. Training certificates are provided and can be used to demonstrate compliance with resource development in ISO 13485 (2016), section 6.2: Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
Courses can be provided to private groups or individuals. Courses and training can be customized as per your specific requirements in terms of topics and duration. Courses can be provided in Spanish as well.
Label review and Cosmetic Product Ingredient Statements
Companies who market cosmetics have a legal responsibility for the safety of their products and ingredients.
Our work is to classify, revision of each ingredient, one-by-one, and file a cosmetic formulation with the FDA. You also can ask us to amend a formulation you have previously filed, or to let FDA know you are discontinuing a formulation.
Proper cosmetic labels and claims are critical to the import and commercial success of cosmetics in the United States. Labeling issues are often the primary cause of delays in customs release or FDA import detentions. The differences between a cosmetic claim and a drug claim can be very subtle, and failure to appreciate these can result in enforcement actions by the FDA.
It is our job to set a right regulatory framework in the client interest.
Natural Health Products & Pharma
Regulatory support & clinical trial research in the Nutraceutical Industry, providing clients across the globe with high-quality services to successfully bring safe and effective natural health products to market, including dietary supplements, ingredients, functional foods and beverages.
Fast-grøwing regulatory and design company that provides end-to-end services
We have spent more time figuring out what you need, and provide unparalleled scientific knowledge in the areas of FDA and global regulatory affairs for IVD, OTC, medical device, and cosmetic companies across the globe.
FDA Registration Approval
Resources
Unique Device Identification (UDI)
A Unique Device Identification (UDI) system has been introduced under Regulations (EU) 2017/745 on medical…
FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy
The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System,…
Our goal is to facilitate the creation of a positive business environment supported by an adequate, modern and efficient team is key to stimulating business expansion.
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