Regulatory
CEIMIC Life Sciences Testing Group
Our Services
Regulatory Solutions
We support regulatory compliance to facilitate your products’ access to domestic and international markets.
At CEIMIC, we offer comprehensive regulatory solutions that simplify the management of registrations, certifications, labeling, and process validation, contributing to regulatory compliance and business continuity.
Registrations, Authorizations, and Certifications
We manage regulatory compliance to facilitate your products’ access to domestic and international markets.
We provide end-to-end support in managing sanitary registrations, permits, and certifications, assisting organizations in complying with current regulations and accessing new markets.
FDA Registrations
We facilitate your products’ entry into the United States market.
-
FDA Registration (Food Facility Registration).
-
US Agent Designation.
-
DUNS Number (UFI) management and updates.
-
FCE (Food Canning Establishment) and SID Registrations.
-
Technical support for FDA inquiries and observations.
International Registrations
We facilitate obtaining sanitary registrations to expedite your products’ access to new markets.
-
Comprehensive sanitary registration management.
-
Technical coordination with manufacturers and contract packers.
-
Technical documentation review.
-
Submission and follow-up with regulatory authorities.
-
Continuous monitoring of international regulatory changes.
Dietary Supplement Registrations
We manage sanitary registrations to facilitate the commercialization of dietary supplements in domestic and international markets.
-
Sanitary registrations.
-
Scope extensions and modifications.
-
Formula and labeling validation.
-
Technical documentation review.
Cosmetics and Household Hygiene Product Registrations
We manage sanitary registrations and regulatory notifications to facilitate the commercialization of cosmetic and household hygiene products.
-
Sanitary registrations and mandatory notifications.
-
Regulatory approvals.
-
Formula auditing.
-
Labeling validation.
-
Registration management for the Andean Community (CAN), the United States, and other international markets.
Regulatory Labeling
We validate food, dietary supplement, and cosmetics labeling to ensure regulatory compliance and facilitate commercialization.
We review labels, formulations, and claims in accordance with the current legislation of each market.
-
Development of nutrition facts panels.
-
Formula validation.
-
Technical label review.
-
Claim evaluation.
-
Regulatory adaptation for domestic and international markets.
Thermal and Aseptic Process Validation
We perform studies and validations to support regulatory compliance and product safety.
-
Thermal and aseptic process validation.
-
Heat penetration and temperature distribution studies.
-
Thermal mapping of equipment, chambers, and warehouses.
-
Record management with regulatory authorities, including the FDA.
Technical and Regulatory Training
We strengthen teams’ technical competencies to contribute to regulatory compliance and continuous improvement.
Training Areas:
-
Food safety and quality.
-
Regulations and regulatory compliance.
-
Management systems.
-
Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
-
Analytical processes and quality control.
-
Tailor-made programs.
Programs are developed by industry-experienced specialists and adapted to the needs of each organization. Upon completion of each activity, participants receive the corresponding certificate.
