Regulatory Compliance Consulting Services for FDA, CMMC 2.0, and ITAR

Connect regulatory requirements with the systems and evidence used to manage them.

Compliance Consulting Services for Ongoing Risk Management

Use regulatory compliance automation to reduce manual work in monitoring, documentation, and reporting.

PCG’s regulatory compliance consulting services help organizations connect applicable requirements with the technology and evidence used to manage them. An engagement can begin with risk assessment and planning, continue through deployment and testing, and extend into ongoing support as requirements or business systems change.

PCG structures the work around five core activities:

Risk Assessment: Identify business-critical compliance risks, including GxP-critical areas where applicable.
Test Strategy: Define the testing scope, responsibilities, objectives, and measures.
Validation Planning: Determine which business processes, platforms, and technologies require testing.
Compliance Testing: Assess practices, processes, platforms, and technologies against defined requirements.
Record Retention: Document the strategy, work performed, resulting actions, validation outcomes, and evidence needed for future reviews or audits.

Explore PCG’s Compliance Services →

What PCG’s Compliance Services Can Support

- - A clearer view of applicable requirements and potential gaps
  - Compliance plans aligned with business and technology priorities
  - More consistent testing and validation practices
  - Better documentation and traceability
  - Stronger coordination among governance, technology, and operational teams
  - Ongoing monitoring as requirements and systems change
  - Better preparation for customer reviews, assessments, and audits

Compliance Advisory, Deployment, and Ongoing Support

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Compliance Advisory

PCG provides compliance consulting services that help organizations define requirements and assess risk. The team can then develop a business case and plan the technology and processes needed to support the compliance program.

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Compliance Deployment

PCG uses its VELOCITY™ methodology to coordinate compliance requirements with technology implementation, integrations, testing, and user adoption. The approach is designed to reduce implementation risk and support more predictable delivery.

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Compliance Support

PCG provides ongoing support for documentation and testing as regulations, governance requirements, or technology environments change. Services may also include monitoring, reporting, and assistance with maintaining traceable evidence.

Manufacturing Regulatory Compliance and Industry Requirements

Manufacturing regulatory compliance can involve overlapping quality, cybersecurity, export-control, contractual, and information-governance requirements. Which requirements apply depends on the organization’s products, the information it handles, its contracts, and where it operates.

PCG helps organizations assess how those requirements affect enterprise platforms and business processes. The work may include FDA regulatory compliance consulting related to regulated systems and electronic records, including applicable 21 CFR Part 11 considerations. PCG can also provide readiness support for CMMC 2.0 compliance or technology planning connected to DFARS cybersecurity compliance.

Where organizations use ITAR compliance software or other systems to manage controlled technical data, PCG can help evaluate access controls, workflows, and supporting documentation. Technology can support a compliance program, but no platform establishes compliance on its own.

Requirements and Frameworks PCG Can Help Address

GDPR
ISO 9001
Applicable FDA requirements, including 21 CFR Part 11
MMAS and applicable DFARS clauses
NIST SP 800-171 and related cybersecurity requirements
CMMC
ITAR and EAR
Canada’s Controlled Goods Program

Industries PCG Supports

Aerospace
& Defense

Automotive &
Suppliers

Warehouse
Distribution

Engineering
& Construction

High
Technology

Industrial
Manufacturing

Advertising
and Media

BioTech &
Pharma

CPG &
Retail

Food &
Beverage

Health &
Beauty

Life
Sciences

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ACHIEVE COMPLIANCE

Leverage technology, including artificial intelligence, to meet complex compliance requirements with our regulatory compliance technology solutions. Easily achieve regulatory and internal governance compliance to improve customer experiences, quality and cost reduction.

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MANAGE BUSINESS RISK

Identify potential gaps earlier and improve the documentation available for internal reviews, customer requirements, assessments, and audits.

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DRIVE NEW OPPORTUNITY

Reduce avoidable manual work so internal teams can focus on the controls and decisions that require their expertise.

Technology validation, documentation, monitoring, and reporting aligned with defined requirements.

Comprehensive technology systems validation, documentation, and reporting

Build a More Predictable Compliance Program

Predictable compliance by overcoming complexity and adoption issues

PCG works from the organization’s current requirements and technology environment to identify gaps, prioritize work, and coordinate practical improvements. The goal is a compliance program that can be documented, monitored, and adapted as the business changes.

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Regulatory Compliance Consulting FAQs

What is PCG’s Compliance as a Service?

PCG’s Compliance as a Service combines advisory and risk assessment with technology deployment, validation planning, testing support, documentation, and ongoing monitoring. It helps organizations connect applicable requirements with the systems and processes used to manage them.

What regulatory requirements and frameworks can PCG help organizations address?

Depending on the engagement, PCG can support technology and process work related to GDPR, ISO 9001, applicable FDA requirements such as 21 CFR Part 11, MMAS and relevant DFARS clauses, NIST SP 800-171, CMMC, ITAR, EAR, and Canada’s Controlled Goods Program. Applicability depends on the organization’s contracts, products, data, industry, and operating locations.

What does the compliance process include?

PCG organizes its approach around five core activities: risk assessment, test strategy, validation planning, compliance testing, and record retention. The specific scope depends on the applicable requirements, the systems involved, and the work the organization has already completed.

Why should compliance be treated as an ongoing program?

Many compliance obligations require continuing controls, documentation, monitoring, reassessment, or recurring affirmations. Treating compliance as a one-time implementation can allow processes, evidence, and system configurations to fall out of alignment as the business or its requirements change.

What are the three core compliance service areas PCG offers?

PCG provides Compliance Advisory, Compliance Deployment, and Compliance Support. Advisory defines requirements and plans the work. Deployment uses PCG’s VELOCITY™ methodology to coordinate implementation and testing. Support helps organizations maintain documentation, monitoring, and reporting as their systems or requirements change.

What industries does PCG’s compliance service support?

PCG supports organizations across aerospace and defense, automotive supply, warehouse distribution, engineering and construction, high technology, industrial manufacturing, advertising and media, biotechnology and pharmaceuticals, consumer products and retail, food and beverage, health and beauty, and life sciences.

How does technology, including AI, factor into PCG’s compliance services?

Technology can help automate workflows, organize evidence, monitor defined controls, and improve reporting. AI may also assist with analysis or the identification of patterns that require review. PCG evaluates where these tools can reduce manual work while preserving the human oversight needed for compliance decisions.

What business benefits can organizations pursue with PCG’s compliance services?

Depending on the engagement, potential benefits include clearer visibility into compliance gaps, more consistent documentation and testing, better coordination among internal teams, a lower manual workload, and stronger preparation for reviews or assessments. Outcomes depend on the organization’s starting point, applicable requirements, and implementation.

How does PCG help organizations manage compliance risks proactively?

PCG uses risk assessment and compliance planning to identify gaps and prioritize work before those gaps disrupt an audit, assessment, customer requirement, or business process. Testing and validation practices are supported by traceable documentation that can be maintained as requirements and systems change.

What should I expect when I contact PCG about compliance needs?

PCG begins by reviewing the requirements affecting the organization, the systems involved, documented processes, and known gaps. From there, PCG can define an appropriate scope for advisory, deployment, validation, monitoring, or ongoing support.