MCD Consulting Services, Inc.

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Our Services

MCD Consulting Services, Inc. is a full-service professional consulting company.

We offer services that include, but are not limited to, validation and regulatory compliance, quality systems and data integrity, remediation projects, process automation, and manufacturing process support.

Remediation Activities

Support in Consent Decree, Warning Letters, or 483 environments, including assessment, remediation planning, and sustainable improvements.

Documentation, Training, and Sustainable Improvements

Development and Execution of Remediation Plans

Assessment of Current State

Pharmaceutical Dosage Forms Supported

MCD Consulting Services, Inc. offers expertise across multiple pharmaceutical dosage forms to meet diverse client needs.

Solid Dosage

Semisolid Dosage

Liquids

Sterile Products

Pharmaceutical and Biotechnology Services

Parenteral

Ophthalmic

Nasal

Biologicals

Biosimilars

Gene Cell Therapy

Medical Devices

Quality Systems & Core Service Areas

MCD Consulting Services specializes in Material Systems and Packaging and Labeling Systems to ensure regulatory compliance and operational efficiency. Our expertise supports pharmaceutical and biotechnology companies in maintaining high-quality standards.

We provide comprehensive Production Systems and Facilities and Equipment Systems services to optimize manufacturing processes. Our solutions help clients enhance productivity while adhering to strict industry regulations.

Our Laboratory Control Systems services focus on data integrity and validation to support accurate testing and quality assurance. We assist clients in implementing robust controls that meet regulatory expectations.

MCD Consulting Services delivers tailored remediation projects and process automation to improve compliance and operational workflows. Our team’s deep industry knowledge ensures effective and sustainable solutions.

Our client-centered approach prioritizes long-term partnerships by aligning services with specific industry needs. We support regulated companies in the pharmaceutical, medical devices, and biotechnology sectors.

With over 28 years of experience, MCD Consulting Services combines strategic consulting and management expertise. We help clients maintain compliance and improve operational performance across core service areas.

Services Provided (Quality, Validation, Compliance & More)

MCD Consulting Services, Inc. offers expertise in Data Integrity, Process Validation, Regulatory Compliance, and Technology Transfers including SUPAC. Our team manages Commissioning, Decommissioning, and Qualification of Equipment, Utilities, Systems, and Facilities to ensure operational excellence.

We support Product Deactivation, Discontinuation, and Reactivation processes, alongside Computer Systems Validation Life Cycle and 21 CFR Part 11 compliance. Our services extend to Cleaning Validation, Laboratory Equipment and System Validation, Packaging Validation, and comprehensive Project Management.

Additional offerings include Master Plans and Technical Documentation, Manufacturing Process Support, Process Automation, Investigations, CAPA, Complaints handling, SOPs Development, Annual Product Review, Pre-approval Inspections, Submissions, Regulatory Audits, Vendor Management, Remediation projects, LIMS/Empower, Training, Process Analytical Technology, Document Control, Periodic Review, Quality Risk Management, ICH Q8, Q9, Q10, Analytical Method Transfer, and other customized services as needed.

From Development to Commercial Support

Our expertise covers troubleshooting, process validation, technology transfers, regulatory audits, and preparation of FDA-required documentation.

Troubleshooting and Development

Registration and Process Validation

Technology Transfers and SUPAC

Day-to-Day Process Support

Audits and Regulatory Site Readiness

Validation Documentation Preparation

Cleaning, Packaging, and Method Transfers

FDA Approval Documentation