Your Questions, Answered
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CMG is a premier quality and regulatory advisory firm helping personal care, cosmetics, OTC, and pharmaceutical manufacturers build compliant, audit-ready operations from FDA registration and QMS design to inspection readiness and operational efficiency.
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We work with manufacturers, brands, and CDMOs/CMOs from companies entering the U.S. market for the first time to established organizations scaling their quality systems or preparing for an FDA inspection.
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FDA Warning Letter & 483 Remediation (Data Integrity, DEG/EG/Methanol/Benzene/Microbial Contamination, Purified Water System Failure, Stability Testing Failure, and many more)
Product Recall
QMS/eQMS Implementation
Computer System Validations
Gap & Risk Assessments
Supplier Qualification
Audit Prep & Regulatory Compliance Review (ISO 9001/17025/22716, 21 CFR 11/210/211, MoCRA)
Regulatory Submission Support
Due Diligence (M&A)
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As a smaller consulting firm, clients work directly with senior-level expertise from day one and not a rotating team of junior consultants. That means faster decisions, deeper familiarity with your business, and advice grounded in real operational experience.
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While our client-base primarily come from the personal care and cosmetic industry, CMG also supports significantly in OTC and pharmaceutical manufacturing along with brands navigating GMP, FDA compliance, and quality system requirements.
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MoCRA (the Modernization of Cosmetics Regulation Act) is U.S. legislation that introduced new FDA registration, facility listing, and safety substantiation requirements for cosmetics manufacturers and brands. CMG helps clients understand and meet these requirements as part of market entry or ongoing compliance.
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Every engagement starts with a complimentary discovery call to understand your current state, compliance needs, and goals. From there, we recommend the right scope of work whether that's a defined project or an ongoing advisory relationship.
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Yes. CMG offers tiered engagement models from project-based support to ongoing retainer relationships scoped to fit your organization's size, needs, and stage of growth.
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Yes, it actually is one of our core competencies. We support inspection readiness, CAPA development, and remediation planning for organizations responding to FDA observations or Warning Letters.
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CMG provides AI/automation strategy and implementation planning at the advisory level. Hands-on deployment (e.g., robotics, system integration) is coordinated through external specialist partners as needed.
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False! CMG does not have a podcast or any media outlet other than what is published by CMG directly however, the Founder of CMG does have a podcast called Manufacturing Made Simple on Spotify and can be found on Instagram @manufacturingmadesimplepod where it is a good resource for many!