Compliance Built to Scale with You

From first-time FDA registration to full-scale quality system overhauls, CMG offers a full range of quality and regulatory advisory services for manufacturers and brands across personal care, cosmetics, OTC, and pharmaceutical industries. Explore our services below, then reserve a consultation to discuss what your business needs.

Our Services

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Essentials

For smaller brands or manufacturers needing baseline compliance coverage, first-time FDA registration, or a defined project rather than ongoing strategic support.

Scope of Work:

  • MoCRA compliance assessment and facility/product registration support

  • Single-issue engagements: audit prep, CAPA review, one-time gap assessment

  • Access to standard checklists/templates

  • Establish training programs and documentation systems

  • Email/async support, response within 2 business days

  • No standing monthly meeting cadence — project-based check-ins only

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Two men are presenting a whiteboard with notes on defect analysis and root cause, while a woman seated at the table is working on a laptop with a chart displayed on the screen. The setting is a modern conference room with large windows and office furniture.

Growth & Acceleration

For manufacturers or brands actively scaling. Whether you are building or maturing a QMS, preparing for inspection, or needing recurring strategic input as you accelerate.

Scope of Work:

  • Everything from the Essentials Package, plus:

  • QMS/eQMS design or optimization support including Validation and Verification of systems and processes

  • Recurring monthly strategy call (1-2x/month) with Managing Partner

  • FDA inspection readiness and Warning Letter remediation support

  • Priority response (1 business day)

  • Ongoing audit support (internal/supplier qualification)

  • Quarterly compliance risk review

  • Continuous improvement program — Quality Engineering driven process analysis, defect/non-conformance trend reviews, and operational efficiency recommendations

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A group of business professionals in a meeting room, sitting at a conference table with various documents, charts, and laptops. In the background, a presentation screen displays a growth chart from 2018 to 2024. On a whiteboard, there are handwritten notes titled 'Target Markets,' 'Product Innovations,' and 'Cost Efficiency.'

Partners

For established CDMOs, CMOs, multi-facility manufacturers, or brands who want CMG embedded as ongoing, senior-level quality/regulatory counsel (not a one-off engagement, but a standing relationship).

Scope of Work:

  • Everything in Growth and Acceleration, plus:

  • Dedicated advisor access on a weekly or as-needed cadence

  • Standing involvement across multiple workstreams (QMS, audits, inspection readiness) simultaneously

  • Board/leadership-level reporting cadence

  • Priority scheduling — treated as CMG's top-priority client relationship, not queued behind project work

  • Priority access to SME-level investigation and validation support (OOS, recalls, process/equipment/method validation) as needed.

  • Operational excellence advisory paired with leadership advisory — supporting quality/operations leadership directly on decision-making, team development, and organizational change management tied to compliance initiatives

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Custom

For clients with a defined but complex, non-recurring need where the scope doesn't fit a standard retainer because it's a discrete, high-stakes project with a start and end point.

Scope of Work (illustrative purpose only, actual scope defined per engagement):

  • M&A quality/regulatory due diligence and post-close compliance risks, restructuring, operational readiness, and business continuity

  • AI/automation strategy advisory (planning-level; explicitly not hands-on deployment)

  • Multi-site QMS rollout or harmonization

  • Health Canada / international regulatory expansion support

  • Root cause investigation and validation services — critical OOS (stability, microbiological, analytical, clinical), product recalls, and validation of processes/systems (purified water, test methods, equipment, manufacturing processes).

  • Any engagement requiring a scoping call before a fee can even be proposed

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