Navigate requirements.
Strengthen compliance.
Get inspection-ready.

Avoid preventable delays caused by incomplete or inconsistent submissions.

DU&T Consulting helps businesses prepare for product-registration processes by reviewing the organisation's documentation and readiness against applicable regulatory requirements.

Our support may include:

• Registration-readiness gap assessment
• Dossier preparation and document review
• Product and facility documentation
• Labelling and packaging compliance review
• Quality-system documentation
• Supporting technical-document review
• Application-readiness verification
• Identification of missing or inconsistent information
• Corrective-action support

Our objective: help you submit a better-prepared application while maintaining your organisation's responsibility for regulatory submissions and declarations.

Know Your Gaps Before the Regulatory Inspection

A regulatory inspection should not be the first time serious GMP weaknesses are discovered.

DU&T Consulting conducts independent GMP gap assessments and mock inspections using applicable regulatory requirements and recognised good manufacturing practices.

Services include:

• GMP gap assessment
• Facility and process readiness review
• Mock inspection
• SOP development and review
• Documentation and record-control systems
• Hygiene and sanitation systems
• Personnel competency assessment
• Production and process controls
• Quality-control systems
• CAPA development
• Root-cause analysis
• Internal audit
• Management review preparation
• GMP staff training
• Follow-up verification of corrective actions

Following the assessment, your organisation receives a structured report identifying gaps, risks, priorities and recommended corrective actions.

Regulatory compliance becomes more sustainable when it is supported by an effective management system.

DU&T Consulting helps regulated organisations establish and improve management systems based on internationally recognised standards, including:

ISO 9001 – Quality Management Systems

Suitable for organisations seeking systematic control of processes, documentation, customer requirements, risk, performance and continual improvement.

ISO 13485 – Medical Devices Quality Management Systems

For medical-device organisations requiring a quality-management framework specifically designed around medical-device regulatory and quality requirements.

Our implementation support includes:

• Gap analysis
• Quality manual and policies
• Process mapping
• SOP development
• Risk-based thinking
• Document and record control
• Internal auditing
• CAPA systems
• Management review
• Staff training
• Certification-readiness assessment

Reliable laboratory results are fundamental to product quality and regulatory confidence.

DU&T Consulting supports testing and calibration laboratories in implementing ISO/IEC 17025 and developing the technical and management controls required to demonstrate laboratory competence.

Our services include:

• ISO/IEC 17025 gap assessment
• Quality-system implementation
• Method validation and verification support
• Measurement uncertainty
• Equipment and calibration controls
• Personnel competency systems
• Sample management
• Quality-control procedures
• Proficiency-testing systems
• Internal audits
• Corrective actions
• Management review
• Pre-accreditation assessment

Build a System That Continues Protecting Patients After Product Approval

For applicable medicinal products, regulatory responsibility continues after market authorisation.

DU&T Consulting helps Marketing Authorisation/Certificate of Registration Holders establish and strengthen pharmacovigilance systems aligned with applicable NAFDAC requirements and internationally recognised good pharmacovigilance practices.

Support can include:

• Pharmacovigilance system gap assessment
• Pharmacovigilance System Master File (PSMF) support
• PV policies and SOPs
• Roles, responsibilities and governance
• Adverse Drug Reaction/Event reporting processes
• Safety information collection
• Case-management processes
• Signal-management framework
• Risk-management processes
• Safety-reporting controls
• Vendor/contractor PV oversight
• Pharmacovigilance quality-management system
• PV internal audits
• Staff training
• Mock pharmacovigilance inspection

Getting a product onto the market is only part of the compliance journey.

DU&T Consulting helps organisations establish systematic processes for monitoring products after market entry.

We can help establish:

• Post-market surveillance plans
• Customer complaint systems
• Adverse-event escalation
• Product-quality complaint investigation
• Trend analysis
• Risk assessment
• Product traceability
• Recall and withdrawal procedures
• CAPA
• Distributor and supply-chain controls
• Safety-data review
• Management reporting

Build Internal Competence, Not Just Documentation

Successful compliance depends on people understanding what is required and consistently applying it.

DU&T Consulting provides public and customised corporate training covering:

GMP | GHP | HACCP | GDP | CAPA | Root Cause Analysis | Risk Management | Internal Auditing | ISO 9001 | ISO 13485 | ISO/IEC 17025 | Pharmacovigilance | Post-Market Surveillance | Quality Management

Training can be delivered on-site, virtually or as customised in-company programmes.