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 what we do and how we work together below.

What We Do

Quality Systems & Regulatory Readiness

Outcome: "Know where you stand, close the gaps, & be ready for any inspection."

  • QMS implementation (first-time and overhaul)

  • Gap assessments & remediation roadmaps

  • Quality manual, SOP, & quality agreement overhaul

  • MoCRA, cGMP, ISO 22716, 21 CFR 210/211, & NSF/ANSI 455 compliance

  • FDA inspection prep & Warning Letter remediation

  • Supplier qualification & audit support

Operational Excellence & Scale-Up

Outcome: "Grow volume, SKUs, & sites without quality breaking."

  • Scale-up & site expansion: capacity planning, validation, tech transfer, & operational readiness

  • Lean / Six Sigma / DMAIC + Root cause analysis & FMEA

  • Cost of Quality modeling + KPI framework & dashboards

  • New product development & tech-transfer on-time delivery

  • Electronic System Stack review (MES, ERP, eQMS, PLCs, etc.)

  • Paper-to-electronic (eQMS) transition & process automation

M&A Change & Risk Management

Outcome: "Buy or integrate with eyes open & keep operations running through the change."

  • Pre-close quality & regulatory diligence

  • Compliance & operational risk assessment

  • Post-close integration & QMS harmonization

  • Restructuring, operational readiness, & business continuity

* Delivered as a custom engagement *

How We Work Together

Three business professionals walking and talking in an office corridor. The woman on the left has dark curly hair, is dressed in a navy pinstripe suit, and is holding a notebook and pen. The man in the middle has short black hair, is wearing a gray suit with a blue tie, and is carrying a briefcase and some papers. The woman on the right has braided hair, is dressed in a green suit, and is holding a laptop and papers. They are engaged in conversation, with a man in a suit and tie walking behind them in the brightly lit corridor.

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 (may include):

  • 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

Begin Now
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 (may include):

  • Capacity and throughput planning for growth (volume, SKU, or site expansion)

  • 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 hands-on process improvement with measured results

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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 (may include):

  • 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

  • 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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Two women having a business meeting in an office. One woman with curly hair in a blazer is speaking, and the other with straight hair in a maroon top is listening. On the table, there are printed documents, a laptop with graphs and charts, and a glass of water. Large windows show a cityscape with tall buildings and a partly cloudy sky.

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)

  • Site expansion and capacity scale-up support

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

Begin Now