Request Multiple Quotes from NSAID Suppliers and Manufacturers

The challenge

The solution

The outcome

Requirements

• - Define demand: product mix, volumes, forecasts, service levels, geographies
• - Confirm specs: API/formulation, dosage forms, strength, packaging, shelf life
• - Set compliance needs: GMP, GDP, GMP/QMS, regulatory registrations, market approvals
• - Screen supplier capability: manufacturing capacity, technology, lead times, continuity plans
• - Verify quality system: COAs, batch traceability, deviation/CAPA, complaint handling, recalls
• - Assess regulatory readiness: DMFs/CTDs, certifications, audit history, inspection outcomes
• - Check safety and pharmacovigilance: adverse event reporting, risk management, change control
• - Evaluate commercial fit: pricing, MOQs, payment terms, Incoterms, total landed cost
• - Review supply resilience: dual sourcing, raw material sourcing, inventory buffers, disruption plans
• - Perform due diligence: financial stability, legal status, sanctions, ESG, labor practices
• - Audit supplier: site visit, documentation review, quality agreement, corrective actions
• - Run samples/trials: lab testing, stability, process validation, packaging validation
• - Negotiate contract: SLAs, KPIs, warranties, liability, confidentiality, termination rights
• - Establish onboarding: approved vendor status, master data, ordering workflow, communication routes
• - Set performance monitoring: OTIF, quality defects, deviations, response times, cost variance
• - Create governance: regular reviews, escalation path, continuous improvement, requalification schedule

Best practices

• 1. Verify the supplier’s regulatory compliance and licensing for all target markets.
• 2. Confirm product quality standards, including GMP, pharmacopeial, and certificate of analysis requirements.
• 3. Require full batch traceability from raw materials through finished goods.
• 4. Assess supplier stability, capacity, and on-time fulfillment history.
• 5. Review packaging, labeling, and serialization requirements for each jurisdiction.
• 6. Validate cold chain, storage, and transport conditions where applicable.
• 7. Check product specifications for active ingredient, dosage form, strength, and shelf life.
• 8. Establish clear pharmacovigilance and adverse event reporting processes with the vendor.
• 9. Audit the supplier’s quality management system and recall procedures.
• 10. Negotiate service-level agreements for lead times, fill rates, and issue resolution.
• 11. Compare total cost of ownership, not just unit price, including logistics, compliance, and returns.
• 12. Ensure anti-counterfeit controls and secure sourcing from authorized channels.
• 13. Review documentation readiness for inspections, import/export, and internal audits.
• 14. Define approval workflows with procurement, quality, legal, and regulatory stakeholders.
• 15. Maintain contingency sourcing plans and inventory buffers for supply disruption.