GMP Consulting Services
GMP Consulting Services, Inc. is a leading FDA regulatory compliance consulting firm specializing in GMPs for pharmaceutical and dietary supplement industries. With over 50 years of experience, they provide comprehensive GMP compliance programs, audits, training, and strategic planning to help companies meet and exceed federal regulations. Their mission is to improve regulatory compliance and ensure clients are never cited by the FDA after following their GMP programs. They emphasize organization, controls, procedures, and internal enforcement, and serve a wide range of clients across the industry.
Industries
Nr. of Employees
small (1-50)
GMP Consulting Services
Deland, Florida, United States, North America
Products
Conformité réglementaire
Services de conseil pour assurer la conformité aux réglementations nationales et fédérales dans l'industrie des sciences de la vie.
Assurance qualité et conformité réglementaire
Services de conseil en assurance qualité pour aider les entreprises pharmaceutiques, biologiques et des dispositifs médicaux à maintenir des niveaux élevés de conformité.
Data Integrity Risk Assessment
Comprehensive data integrity risk assessment services for paper-based, computer-based, and hybrid systems to ensure compliance with Health Canada, FDA, and other regulatory agency expectations.
Perform GAP Assessments
Routine GMP GAP Assessments conducted for clients to ensure companies meet regulatory GMP requirements, covering general assessments or specific topics such as Data Integrity, Cleaning Validation, QMS, Analytical Services, and New Regulatory Guidance.
Supplier Evaluation and Auditing
Evaluation and qualification of suppliers through assessments and site audits for raw materials, active pharmaceutical ingredients, packaging components, and contract services.
Support QA Activities
Consulting and support services to assist client teams with batch review, product release, deviations, CAPAs, change controls, annual quality product reviews, and validation protocols.
Conformité réglementaire
Services de conseil pour assurer la conformité aux réglementations nationales et fédérales dans l'industrie des sciences de la vie.
Assurance qualité et conformité réglementaire
Services de conseil en assurance qualité pour aider les entreprises pharmaceutiques, biologiques et des dispositifs médicaux à maintenir des niveaux élevés de conformité.
Data Integrity Risk Assessment
Comprehensive data integrity risk assessment services for paper-based, computer-based, and hybrid systems to ensure compliance with Health Canada, FDA, and other regulatory agency expectations.
Perform GAP Assessments
Routine GMP GAP Assessments conducted for clients to ensure companies meet regulatory GMP requirements, covering general assessments or specific topics such as Data Integrity, Cleaning Validation, QMS, Analytical Services, and New Regulatory Guidance.
Supplier Evaluation and Auditing
Evaluation and qualification of suppliers through assessments and site audits for raw materials, active pharmaceutical ingredients, packaging components, and contract services.
Support QA Activities
Consulting and support services to assist client teams with batch review, product release, deviations, CAPAs, change controls, annual quality product reviews, and validation protocols.
Services
Hourly retained consulting engagement providing general GMP and regulatory compliance support under a defined retainer agreement.
Turnkey program delivering an integrated GMP system: SOPs, forms, templates, quality manuals, training, and implementation support to meet FDA GMP requirements.
Contracted monthly program including quarterly audits and reports to maintain GMP certification and ongoing compliance.
Per-diem on-site consulting visits for assessments, implementation support, or remediation activities.
Technical support covering product formulation, raw material and equipment procurement, facility design, and other manufacturing support services.
Courses and workshops focused on SOP writing and meeting cGMP requirements, delivered as instructor-led training and client-specific workshops.
Hourly retained consulting engagement providing general GMP and regulatory compliance support under a defined retainer agreement.
Turnkey program delivering an integrated GMP system: SOPs, forms, templates, quality manuals, training, and implementation support to meet FDA GMP requirements.
Contracted monthly program including quarterly audits and reports to maintain GMP certification and ongoing compliance.
Per-diem on-site consulting visits for assessments, implementation support, or remediation activities.
Technical support covering product formulation, raw material and equipment procurement, facility design, and other manufacturing support services.
Courses and workshops focused on SOP writing and meeting cGMP requirements, delivered as instructor-led training and client-specific workshops.
Expertise Areas
- FDA GMP regulatory compliance
- GMP quality systems and SOP development
- GMP auditing and remediation
- Pharmaceutical and dietary supplement formulation support
Key Technologies
- Process control system design
- Quality management system implementation
- SOP authoring and document control
- GMP auditing methodologies
News & Updates
Announcement of a new cost-effective GMP compliance program.
Promotion of free GMP audits to companies.
Announcement of new CEO appointment.
Introduction of a new consulting company specializing in GMPs for dietary supplements.
An article discussing the concept of quality in manufacturing.
An article on how to follow GMP guidelines while improving productivity.
Announcement of a new cost-effective GMP compliance program.
Promotion of free GMP audits to companies.
Announcement of new CEO appointment.
Introduction of a new consulting company specializing in GMPs for dietary supplements.
An article discussing the concept of quality in manufacturing.
An article on how to follow GMP guidelines while improving productivity.