Quality & Compliance
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NGT BioPharma Consultants’ Quality & Compliance strategic and operational consulting services span all phases of drug development for both small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy, and other new modalities), beginning at the preclinical stage while extending through commercialization and life-cycle management.
Our Quality & Compliance consultants work seamlessly with other functional areas, such as Nonclinical, Clinical, CMC, and Regulatory, to provide services that include, but are not limited to, the services highlighted below:
- Full service GXP Quality Assurance on behalf of Product Sponsors
- Pharmaceutical Quality System (PQS) strategy, design, and implementation, incorporating Quality Risk Management, Knowledge Management, and Management Controls as per ICH Q8, Q9 and Q10
- Third-Party Supplier and Service Provider qualification and management, including assessments, audits, Quality Agreements, and performance monitoring
- GXP gap assessments, audits (internal, due diligence), and regulatory inspection readiness
- GXP documentation development and/or review (e.g., procedures, protocols, reports, analytical methods, specifications, batch records, training materials, master plans)
- Secure GXP compliant electronic document storage and processing (EDMS) services
- GXP training program design, development, implementation, and delivery
- Regulatory action response and remediation support (e.g., FDA 483’s, Warning Letters, Consent Decree, and equivalent)
Quality Management System (QMS) support to include, 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
PRECLINICAL AND CLINICAL DRUG DEVELOPMENT
- Assess IND-enabling studies for submission readiness
- Establish a local or global regulatory strategies, including plans for leveraging expedited pathways and special programs
- Optimize, create and submit meeting requests, meeting packages and briefing books
- Provide IND and CTA maintenance (initial submissions, amendments, annual and periodic reports and closure
REGISTRATION
- Prepare companies for Pre-NDA meetings and scientific advice
- Create and manage Emergency Use Authorizations submissions
- Provide NDA/BLA/MAA dossier authoring and regulatory project management
- Priority review requests
- Managing responses to health authority questions
ADDITIONAL SERVICES
- U.S. Agent for non-U.S. entities
- Regulatory due diligence, gap analyses and risk management
- Rare Pediatric Disease Designations
- Special Protocol Assessments
- Expedited program requests (Breakthrough, Fast Track, Priority Review, Accelerated Approval)
- Orphan Drug Designations
- Regulatory strategy refinement and optimization
- Full service GXP Quality Assurance on behalf of Product Sponsors
- Pharmaceutical Quality System (PQS) strategy, design, and implementation, incorporating Quality Risk Management, Knowledge Management, and Management Controls as per ICH Q8, Q9 and Q10
- Third-Party Supplier and Service Provider qualification and management, including assessments, audits, Quality Agreements, and performance monitoring
- GXP gap assessments, audits (internal, due diligence), and regulatory inspection readiness
- GXP documentation development and/or review (e.g., procedures, protocols, reports, analytical methods, specifications, batch records, training materials, master plans)
- Secure GXP compliant electronic document storage and processing (EDMS) services
- GXP training program design, development, implementation, and delivery
- Regulatory action response and remediation support (e.g., FDA 483’s, Warning Letters, Consent Decree, and equivalent)
- Quality Management System (QMS) support to include, 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
NGT’s Quality & Compliance consultants are experienced professionals in all phases of drug development, including preclinical, clinical, registration, commercialization, and life cycle management, and cover a wide range of modalities.
Working with Big Pharma Globally
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Get in touch
For more information pertaining to Regulatory Strategy & Application Preparation please contact Roger or Rachel on the details below. Alternatively please fill in the form and our team in this field will get back to you.
New Enquiry
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