Your FDA MoCRA Compliance Partner

Achieve GMP Regulatory Success Today

Elevate Your Compliance with Customized GMP Solutions

The Modernization of Cosmetics Regulation Act (MoCRA) ushers in a new era of cosmetic safety and transparency. At cGMP Consulting, we draw on more than 23 years of GMP expertise to guide businesses through MoCRA’s regulations. Our consulting services help streamline your operations to meet the highest standards, simplifying the path to compliance. Trust us to be your guide, ensuring you not only meet the new regulatory requirements but also exceed consumer expectations.

Tailored GMP Plans for MoCRA Compliance

Discover our customized GMP plan, designed to meet MoCRA’s strict requirements and your unique operational needs.

Implementing a new system or updating an established GMP system can be time and resource intensive. Let us put our expertise to work to take this burden off your organization.

Here’s our approach:

1

GMP Gap Assessment

We conduct a comprehensive gap assessment of your current processes and procedures. This expert analysis forms the foundation for leading your organization toward full compliance.

2

Standard Operating Procedures (SOPs)

We develop customized SOPs that meet all aspects of MoCRA’s new requirements while aligning with your existing internal systems. We work closely with you to preserve the integrity and unique aspects of your procedures while ensuring regulatory compliance.

3

Documentation & Record-Keeping

We ensure that all manufacturing and testing processes are thoroughly documented to prevent regulatory issues. Whether your records are paper-based or electronic, we assist in capturing and maintaining your essential reports.

4

Employee Training & Education

We empower your team with the knowledge to implement and sustain compliance. Introducing new systems can be challenging, but we provide the necessary training to help your staff embrace and maintain a robust quality system.

Elevate Your Brand with Our Expertise

Unlock the full potential of your operations with cGMP Consulting.

We ensure your compliance with MoCRA and enhance your operational efficiency and brand integrity through:

  • Compliance Expertise: Leverage our deep understanding of regulatory requirements.
  • Tailored Project Management: We will manage your project so you can focus on maintaining your business.
  • Significant Time Savings: Resources can be tight. Let us add bandwidth to implement these vital requirements.
  • Enhanced Brand Integrity: Build a strong reputation for reliability and safety.

MoCRA Services

Each service is designed with your success in mind

Facility Registration

Facility Registration

Understand the FDA registration requirements for your facility. Our team of experts will guide you through each step to ensure a seamless and successful registration.

Product Listing

Product Listing

We can consult and also manage the process of listing your cosmetic products with the FDA under MoCRA. Our expert guidance will help you avoid common pitfalls and ensure a seamless registration.

Safety Substantiation

Safety Substantiation

Our experts will work with you to understand and implement the safety standards and approved testing methods mandated by MoCRA to ensure your products are safe for consumers.

Product Labeling Support

Labeling Support

Our team will guide you through MoCRA’s labeling requirements, including fragrance allergens and professional use instructions, ensuring your products meet regulatory standards.

Adverse Events Reporting

Adverse Events Reporting

Implement the requirements for adverse event classification and FDA reporting. Learn best practices for managing mandatory recalls and maintaining compliance.

Customized GMP System

Customized GMP

Understand the GMP requirements under MoCRA. Our team will guide you in implementing and maintaining these customized GMP procedures to ensure product quality and safety.

Blogs

FDA Critical Deadlines

Stay ahead of MoCRA’s critical deadlines with cGMP Consulting
Timeline

July 1, 2024

• Facility Registration & Product Listing
• Adverse Event Reporting
• Safety Substantiation & Recall Authority

December 29, 2024

• Disclose Fragrance Allergens
• Provide Label Contact Information
• GMP Rule Announced

December 29, 2025

• GMP Final Rule
• PFA Report

Resources

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

MoCRA BILL

Registration & Listing of Cosmetic Product Facilities and Products

Product Testing of Cosmetics

Good Manufacturing Practices for Cosmetic Products

Draft Guidance for Industry: Cosmetic Good Manufacturing Practices

Public Meeting: Good Manufacturing Practices for Cosmetic Products

Summary of Cosmetics Labeling Requirements

Achieve Compliance Success with cGMP Consulting

Staying compliant with MoCRA is crucial for your business’s success. Partner with cGMP Consulting to ensure you meet these new requirements efficiently. Our expertise and support will help you maintain the highest standards of product safety and quality.

We tailor our solutions to meet your specific needs, enabling you to focus on your strengths. Our proactive approach helps you stay ahead of regulatory changes, allowing for smooth business operations and peace of mind.

Don’t let MoCRA regulations overwhelm you. Contact us today to discover how cGMP Consulting can assist with MoCRA compliance and enhance your business’s success in a dynamic regulatory landscape.