Elexes Medical Consulting LLC

About

Elexes was born to help Entrepreneurs, Medical Device, Drugs and Biologics Companies meet regulatory and quality standards, overcome regulatory hurdles, stay in compliance, and launch their break through products into the US, EU, Indian and other international markets.

Why choose Elexes:
High quality
Competitive prices
Reduced time to the market
Frequent updates on project status
Highly dedicated and committed team of professionals

Medical Devices
Across the world, Medical Devices are regulated by several regulatory bodies. A Medical Device life-cycle consists of different phases, and at each phase a Manufacturer must comply with regulatory standards and requirements laid out by the country specific regulatory bodies.

Elexes is well experienced in all the phases of a Medical Device life-cycle: Elexes supports companies in defining product specifications, design inputs, outputs and testing needed at the prototype phase, testing and protocol and report writing at the preclinical and clinical stage, regulatory clearance/approval before the marketing phase, and finally at the commercial use phase, meeting compliance requirements to ensure continued safety and effectiveness of products.

Foods and Cosmetics
The following categories of foods and cosmetics are regulated.

Foods:
Dietary supplements
Bottled water
Food additives
Infant formulas

Cosmetics:
Color additives found in makeup and other personal care products
Skin moisturizers and cleansers
Nail polish and perfume

We can -
Create FDA compliant supplement and nutritional fact sheets
Review your labeling and advertising material for compliance with the FDA
Review of additives and ingredients used in cosmetics

Keywords

regulatory submissions, regulatory compliance, 510 & international submissions, iso 13485, premarket submissions, postmarket submissions

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