cGMP Consulting
cGMP Consulting Inc. has been helping clients stay compliant with current Good Manufacturing Practices (cGMP) and implement new technologies since 2001. They offer expert support in cGMP validation, engineering, audits, regulatory compliance, and the implementation of electronic GMP systems. Their services include compliance consulting, GMP certification audits, equipment qualification, validation, and support for various regulated industries including pharmaceuticals, biologics, dietary supplements, cosmetics, and food. They are ISO accredited and have a team of over 75 engineers and consultants dedicated to regulatory compliance and operational excellence. They also provide tailored auditing solutions, risk management strategies, deviation investigations, and technical writing services to enhance compliance and product quality.
Industries
Nr. of Employees
medium (51-250)
cGMP Consulting
cGMP Consulting Inc., 1234 Industry Rd, City, State, ZIP
Products
Auditing
Provides comprehensive auditing services to help organizations achieve compliance with applicable regulations, including internal audits, supplier qualification audits, and cGMP gap assessments.
Engineering Services
Offers technical expertise and support for integrating new technologies into manufacturing processes and ongoing project support, including the development of crucial documents like URS, SOPs, and risk assessments.
Facilities, Utilities, Equipment (FUE) Qualification Support
Ensures optimal performance of facilities and systems through customized qualification support, including evaluation and identification of critical systems requiring qualification.
Computer System Validation
Validates computerized systems from stand-alone instruments to enterprise-level enablement, ensuring compliance with regulatory and industry standards through strategic testing protocols.
Medical Device Compliance
Provides consulting services for medical device manufacturers, including quality assurance, equipment qualification, process validation, and risk management to ensure regulatory compliance.
Process and Cleaning Validation
Offers validation services to ensure that manufacturing processes and cleaning procedures meet regulatory standards and maintain product quality.
Auditing
Provides comprehensive auditing services to help organizations achieve compliance with applicable regulations, including internal audits, supplier qualification audits, and cGMP gap assessments.
Engineering Services
Offers technical expertise and support for integrating new technologies into manufacturing processes and ongoing project support, including the development of crucial documents like URS, SOPs, and risk assessments.
Facilities, Utilities, Equipment (FUE) Qualification Support
Ensures optimal performance of facilities and systems through customized qualification support, including evaluation and identification of critical systems requiring qualification.
Computer System Validation
Validates computerized systems from stand-alone instruments to enterprise-level enablement, ensuring compliance with regulatory and industry standards through strategic testing protocols.
Medical Device Compliance
Provides consulting services for medical device manufacturers, including quality assurance, equipment qualification, process validation, and risk management to ensure regulatory compliance.
Process and Cleaning Validation
Offers validation services to ensure that manufacturing processes and cleaning procedures meet regulatory standards and maintain product quality.
Services
Planning and execution support for commissioning, facility qualification and process validation activities across regulated facilities.
Engineering services including URS development, machine/process risk assessments, procurement support (RFP/PO) and on-site engineering integration.
Operational assistance including calibration program management, microbial sampling, preventive maintenance planning and maintenance coordination.
Project and program management for facility projects, new product introduction and cross-functional program delivery in regulated environments.
Development of QMS, SOPs, document control, adverse event reporting workflows and regulatory readiness for FDA and MoCRA requirements.
Internal GMP audits, supplier audits, PAI readiness, due diligence assessments and ISO/IEC 17020-accredited GMP certification audits with remediation planning.
Planning and execution support for commissioning, facility qualification and process validation activities across regulated facilities.
Engineering services including URS development, machine/process risk assessments, procurement support (RFP/PO) and on-site engineering integration.
Operational assistance including calibration program management, microbial sampling, preventive maintenance planning and maintenance coordination.
Project and program management for facility projects, new product introduction and cross-functional program delivery in regulated environments.
Development of QMS, SOPs, document control, adverse event reporting workflows and regulatory readiness for FDA and MoCRA requirements.
Internal GMP audits, supplier audits, PAI readiness, due diligence assessments and ISO/IEC 17020-accredited GMP certification audits with remediation planning.
Expertise Areas
- Commissioning, qualification and validation (CQV)
- Validation engineering and execution oversight
- GMP auditing and certification
- Quality management system (QMS) development and documentation control
Key Technologies
- IQ/OQ/PQ equipment qualification protocols
- FAT/SAT acceptance testing
- Electronic Quality Management Systems (eQMS) and eGMP platforms
- Sensor- and machine-vision inspection systems
News & Updates
Supported a major pharmaceutical manufacturing expansion from initial design through validation and operational readiness, including engineering design, procurement support, compliance oversight, and protocol execution.
Guidance on compliance with dietary supplement cGMP regulations.
Assessment and guidance to prepare manufacturing facilities for GMP certification.
An overview of the validation engineering services provided by cGMP Consulting.
Guidance for dietary supplement manufacturers to meet cGMP standards.
cGMP Consulting is ISO accredited and performs GMP certification audits.
Supported a major pharmaceutical manufacturing expansion from initial design through validation and operational readiness, including engineering design, procurement support, compliance oversight, and protocol execution.
Guidance on compliance with dietary supplement cGMP regulations.
Assessment and guidance to prepare manufacturing facilities for GMP certification.
An overview of the validation engineering services provided by cGMP Consulting.
Guidance for dietary supplement manufacturers to meet cGMP standards.
cGMP Consulting is ISO accredited and performs GMP certification audits.