Pharma Direct supports FDA-registered 503B outsourcing facilities and healthcare buyers with compliant operations, inspection readiness, and commercially reasonable pricing strategies.
Our advisory model bridges regulatory compliance and commercial execution across the 503B ecosystem.
End-to-end support for FDA registration, facility readiness, and compliant market entry.
Mock inspections, gap assessments, Form 483 response support, and remediation execution.
Quality systems design, aseptic process oversight, SOP development, and data integrity alignment.
Support for capacity expansion, new product introductions, and growth aligned with enforcement trends.
Interim QA and compliance leadership for executive teams, boards, and investors.
Independent assessment of 503B manufacturers for quality, reliability, and operational maturity.
Market-based benchmarking to ensure pricing is competitive and commercially reasonable.
Advisory support for sourcing strategies, volume commitments, and long-term supply agreements.
Submit an inquiry to discuss sterile manufacturing support, inspection readiness, or strategic sourcing and pricing advisory.