Quality & Compliance
“If you think compliance is expensive – try non-compliance.”
– Paul McNutty, Former U.S. Deputy Attorney General
– Paul McNutty, Former U.S. Deputy Attorney General
It’s not uncommon for small biotech and biopharmaceutical companies to overlook, or not fully comprehend, the vital importance of Quality & Compliance when formulating their drug development plans and budgets.
The International Conference on Harmonization (ICH) Industry guidance recommends that serious consideration be given to Quality Assurance (QA) very early in the process. Companies that do not pay proper attention to Quality run the risk of downstream consequences such as delayed study starts and product approvals due to regulatory agency actions (e.g., clinical study holds, FDA 483s, Warning Letters etc.).
Services
NGT BioPharma Consultants’ experienced Quality & Compliance team provides expertise supporting the full range of global regulatory compliance requirements. They work seamlessly with other functional areas within our diverse consulting group, including e.g., CMC, Nonclinical Development, Clinical Development, and Regulatory, to provide services that include, but are not limited to the following:
- Full service GXP Quality Assurance on behalf of Product Sponsors
- Lead and/or support GXP Auditing (onsite or remote) including regulatory inspection readiness, and regulatory action response and remediation activities
- Pharmaceutical Quality System (PQS) strategy, design, and implementation, incorporating Quality Risk Management, Knowledge Management, and Management Controls as per ICH Q8, Q9 and Q10
- GXP documentation development and/or review (e.g., procedures, protocols, reports, analytical methods, specifications, SOP’s, batch records, training materials, master plans)
- Secure GXP compliant electronic document storage and processing (EDMS) services
- GXP training program design, development, and implementation
- Regulatory action response and remediation support (e.g., FDA 483’s, Warning Letters, Consent Decree, and equivalent)
- Third-Party Supplier and Service Provider qualification and management, including assessments, audits, Quality Agreements, and performance monitoring
- Quality Management System (QMS) needs assessment, design, implementation and operation including but not limited to:
- Batch certification
- Data integrity
- Deviation investigation and reporting
- Laboratory controls
- Change management
- Corrective Action/Preventive Action (CAPA) strategy and effectiveness
- Validation/qualification of facilities, utilities, equipment, analytical methods, processes, and computer systems
Get in touch
For additional information pertaining to the Quality & Compliance service area, please contact Ronay LeBlanc or our CEO Michael O'Brien via the contact information provided below. Alternatively, please fill out the New Inquiry form and we will get back to you within 48 hours.
