Quality Documentation Review
Facilitate the collection and preliminary review of available quality-system documentation and relevant compliance records.
Core Service
Supplier Due Diligence & Capability Assessment
A Structured View of Supplier Suitability
Selecting a pharmaceutical supplier or manufacturing partner requires more than a price comparison. Pharma Nexus can coordinate a structured due-diligence process to help customers understand a supplier's suitability across key business and operational dimensions.
Assessment Areas
1
Quality Systems & Compliance Assessment
Evaluate the supplier's quality framework, compliance readiness and quality management practices to support informed supplier qualification decisions.
Quality System Evaluation
Coordinate the assessment of supplier responses to customer-defined quality questionnaires and supporting documentation.
Quality Stakeholder Engagement
Facilitate discussions with supplier quality teams and coordinate independent specialist reviews or audits, where required.
Gap Identification & Follow-up
Highlight identified documentation gaps, outstanding compliance-related queries and areas requiring further assessment or corrective action.
2
Regulatory Capability Assessment
Assess the supplier's regulatory capabilities and experience in supporting applicable product registration requirements and target-market compliance expectations.
Regulatory Documentation Review
Coordinate the collection and review of relevant licences, registrations, certificates and regulatory documentation, as applicable.
Regulatory Experience Assessment
Evaluate available information on the supplier's experience in supporting product registrations and regulatory requirements across relevant markets.
Regulatory Stakeholder Coordination
Facilitate engagement between customer and supplier regulatory teams to clarify requirements and address outstanding queries.
Regulatory Gap Identification
Identify missing documentation, potential information gaps and matters requiring further review by qualified regulatory specialists.
3
Production & Manufacturing Capability Assessment
Evaluate the supplier's manufacturing infrastructure, technical capabilities and production readiness against the customer's product and supply requirements.
Manufacturing Infrastructure Review
Assess available information on manufacturing facilities, dosage forms, product categories, equipment and relevant process capabilities.
Capacity & Supply Capability Assessment
Review supplier-provided information on production capacity, utilisation, lead times and production planning.
Technical & Operational Alignment
Facilitate discussions on technology transfer, product development, scale-up, packaging and supply requirements, where applicable.
Site Visit & Technical Assessment Coordination
Coordinate supplier site visits and technical discussions within the agreed scope of the engagement.
Due-Diligence Process
- Agree the assessment scope and supplier-selection criteria with the customer.
- Request relevant information and documentation from the supplier.
- Coordinate document review and discussions with the appropriate stakeholders.
- Compile observations, outstanding questions, potential risks and information gaps.
- Support follow-up and coordinate specialist assessments or formal audits where required.
- Present a structured summary to support the customer's supplier decision.