Overview

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks a transformative shift in how cosmetics are regulated in the United States. As the first major update to FDA cosmetic laws since 1938, MoCRA enhances FDA’s authority to ensure the safety and transparency of cosmetic products, impacting manufacturers, contract manufacturers, and brand owners alike.

At Techsol Life Sciences, we support cosmetic manufacturers, importers, and distributors in aligning with MoCRA’s evolving requirements through our Regulatory Compliance and Advisory Services. We provide end-to-end solutions that ensure your products are not only market-ready but inspection-ready.

Services Offered at Techsol

Facility Registration & Renewal

Assistance with initial FDA registration of domestic and foreign facilities involved in manufacturing or processing cosmetic products.
Timely biennial renewal support to maintain valid facility registrations.
Guidance on maintaining registration eligibility and avoiding suspension due to product safety concerns.

Cosmetic Product Listing

Preparation and submission of FDA-compliant product listings including formulation details, product categories, and responsible person data.
Annual update management to ensure continued compliance.

Safety Substantiation Consulting

Evaluation of existing safety data and preparation of safety substantiation documentation.
Support in identifying scientifically valid alternatives to animal testing.
Record-keeping guidance for maintaining safety data in an FDA-accessible format.

Serious Adverse Event Reporting (SAER)

Setup and implementation of internal monitoring systems for identifying and tracking adverse events.
Preparation and electronic submission of Form FDA 3500A for serious adverse events within the 15-business-day reporting window.
Ongoing support for follow-up reporting and inspection readiness.

Good Manufacturing Practices (GMP) Advisory

Strategic guidance to establish and implement cosmetic GMPs in line with upcoming FDA regulations.
Conducting internal GMP gap assessments, SOP development, and quality system design.
Support in documenting manufacturing controls for FDA inspection compliance.

Fragrance Allergen & Talc-Testing Compliance

Consulting support for fragrance allergen labeling as per anticipated FDA requirements.
Development of testing protocols and vendor qualification for asbestos testing in talc-containing cosmetics.

MoCRA Readiness Audits & Regulatory Strategy

Conducting internal MoCRA readiness assessments for product portfolios and facilities.
Creation of a compliance roadmap, including required documentation, reporting systems, and stakeholder roles.
Ongoing regulatory intelligence tracking for updates on PFAS assessments, GMP rulemaking, and additional FDA guidance.