Adhering to Quality Standards

FDA 21 CFR

ISO Standards

GLP Compliant

HIPAA Compliant

GCP Guidelines

State Privacy

Strategic & Global Alliances

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Client Success Rate

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Years of Industry Experience

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Businesses Supported

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Defining Excellence in Business Consulting

Chesapeake Quality Group is a trusted business consulting firm with over 15 years of experience, supporting startups, growing businesses, and established enterprises. We focus on delivering sustainable growth through clear strategies, practical solutions, and expert guidance tailored to each client’s goals.

Expert Business Consulting Solutions

Comprehensive solutions tailored to the unique challenges of the pharmaceutical and life sciences industries.

QA Consulting Services

Expert quality assurance consulting tailored to the pharmaceutical industry. We ensure compliance with GLP, GMP, GCP, and GDocP standards through audits and risk assessments.

GLP/GCP/GMP/GDP Coursework

Specialized training programs covering critical regulatory frameworks. Equip your professionals with the knowledge needed to maintain compliance.

Digital Resources

A growing library of digital SOPs, templates, and guidance documents designed to streamline quality processes and support staff development.

Notarization

Certified notary services for clients requiring official document authentication in support of business operations.

Proofreading

Professional proofreading services to ensure clarity, accuracy, and consistency in business-critical documents and communications.

Quality-Driven Consulting You Can Trust

With over 15 years of experience, we deliver strategic, reliable, and results-focused consulting solutions that help businesses grow confidently.

Industry Compliance

Deep expertise in GLP, GMP, GCP, and GDocP standards ensures your organization stays audit-ready.

Tailored Solutions

We don't believe in one-size-fits-all. Our consulting is customized to your specific operational needs.

Proven Results

A track record of helping organizations optimize performance and achieve sustainable growth.

Our Methodology

A proven, four-step approach to achieving and maintaining pharmaceutical quality excellence.

Initial Consultation

We discuss your specific needs and regulatory environment to determine the best path forward.

Strategy Design

Our experts design a tailored roadmap to optimize your compliance posture.

Implementation

We work alongside your team to deploy new SOPs, training programs, and quality controls.

Sustainment

Ongoing support to maintain your compliance status and ensure readiness.

Insights That Drive Business Excellence

Explore expert insights, industry updates, and practical strategies designed to improve quality, compliance, and long-term business performance.

January 5, 2026

Transforming Operations with Digital SOPs

January 5, 2026

Finding Balance in High-Pressure Environments

January 5, 2026

Navigating the New FDA Guidelines

Lisa AnnMarie Fleshman

Founder & Principal Consultant

With over 20 years of experience in pharmaceutical quality assurance and regulatory compliance, AnnMarie has dedicated her career to helping organizations navigate the complex landscape of GxP standards. Her expertise spans global quality systems, risk management, and inspection readiness for both emerging biotechs and established pharmaceutical companies.

Digital Resources

Streamline your quality operations with our verified templates and tools.

Standard Operating Procedures

Comprehensive SOP templates compliant with 21 CFR Part 11 and ICH guidelines.

Inspection Readiness Checklists

Step-by-step audit tools to ensure your facility is always prepared for regulatory visits.

GxP Training Manuals

Ready-to-deploy training modules for staff on GMP, GLP, and GDP fundamentals.

Beyond Compliance

Resources to help you find balance, inspiration, and personal growth in your professional journey.

Creative Resources & Coloring Books

Discover our “Quality & Calm” series of adult coloring books designed specifically for professionals in high-stress environments. Plus, explore high-quality art supplies to fuel your creativity.

The Quality Mindset Book Series

Coming soon: An insightful book series that chronicles real-world experiences, lessons learned, and the human side of quality assurance. Sign up for updates to be the first to know when it launches.

Client Success Stories

Trusted by leading pharmaceutical and biotechnology organizations.

Sarah Jenkins VP of Quality, BioTech Innovations

Chesapeake Quality Group transformed our QMS ahead of our first FDA inspection. Their depth of knowledge is unmatched.

Dr. Michael Chen Director of R&D, PharmaCorp

The training programs provided were practical and immediately applicable. Our team is now fully aligned on GLP standards.

Robert Vance COO, MedLife Solutions

Professional, thorough, and efficient. Their audit revealed critical gaps we missed, saving us from potential regulatory action.

Frequently Asked Questions

Our FAQs section answers common questions about our consulting services, compliance support, digital SOPs, and quality management solutions. We help organizations understand our processes, timelines, and deliverables clearly, ensuring transparency, confidence, and informed decision-making at every stage of engagement.

What industries do you specialize in?

We primarily serve the pharmaceutical, biotechnology, and medical device sectors, with deep expertise in GLP, GMP, GCP, and GDP compliance.

Do you offer remote auditing services?

Yes, we conduct both on-site and remote audits using secure digital platforms to ensure comprehensive review while minimizing disruption to your operations.

Can you help with FDA 483 response and remediation?

Absolutely. Our team specializes in helping organizations address audit findings, develop CAPA plans, and communicate effectively with regulatory bodies.

What is the typical duration of a gap analysis project?

Most initial gap analyses take 2-4 weeks, depending on the scope of your quality system and the size of your facility.

Are your training programs customizable?

Yes, we tailor all training modules to your specific SOPs and operational needs, ensuring your team learns relevant, practical applications.

Your First Step Toward Quality Excellence

We’re ready to understand your business needs and deliver tailored consulting solutions. Share your details, and our experts will connect with you shortly to guide your growth.

Number

240-315-5559

Address

519 West 22nd St #100A, Sioux Falls, SD, United States, 57105

Email

afleshman@
chesapeakequality
group.com

Working Hours

8am-5pm CST