KAELTIA Consulting, with more than 15 years of experience in the regulatory sector, has taken a new step to come along with companies in their international expansion. KAELTIA Consulting from its office in Miami, offers specialized services to comply with all U.S. regulations, ensuring that clients and associates, as well as potential clients are ready to enter and grow in this competitive market.
The services offered are designed to cover all the regulatory needs of companies wishing to operate in the U.S. market, providing the necessary support at every stage of the regulatory process.
The complexity of regulatory requirements in the United States, especially for products overseen by the FDA, EPA and USDA, can be a significant challenge for companies. It is for this reason that KAELTIA Consulting is an excellent partner in the management of these procedures, allowing their clients to focus on their strategic objectives.
Compliance with federal regulations is essential to avoid penalties, product rejections at the border, or delays in distribution, this is why KAELTIA Consulting specializes in ensuring a smooth regulatory transition to ensure success in the U.S. market.
Some of the services offered by Kaeltia Consulting include:
- Registrations of biostimulant, biocontrol, fertilizer, pesticide, cosmetic and medical device products with the respective evaluating agencies.
- Strategic review of the authorization and planning process and its planning.
- Regulatory diagnosis, labelling and analytical review of product data destined for FDA, EPA and USDA’s processes.
- Processing of FDA facility registrations for companies.
- FCE and SID registrations for acidified and low acid products.
- FDA/CBP export notifications (Web entries – Prior Notice).
- FDA product code identification support.
- Management of tests in accredited laboratories.
About us, how can Kaeltia Consulting help companies?
With a solid track record and an expert team in U.S. regulations, KAELTIA Consulting is positioned as the ideal partner to ensure that your expansion to the U.S. is fast, efficient and fully compliant.
KAELTIA Consulting provides specialized support in scientific and regulatory affairs to meet the regulatory compliance needs of companies, complying with the criteria established by the Agencies and the new regulatory frameworks.
Don’t let regulatory challenges be an obstacle to your company’s growth – we are here to help!
For more information about our services, please visit www.kaeltia.com or contact us at info@kaeltia.com. We’ll be happy to help.
