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QA Consulting, Quality Risk Management & Digital Systems — From Product Research to Market
Phoenix Atlantic partners with life-science and agro-industrial organizations to convert regulatory complexity into measurable commercial capability. We provide, audit-ready QA and regulatory leadership into your program, then execute the systems, supplier networks and validated workflows that make compliance repeatable and scalable.
Our core strength is practical delivery: enterprise Quality Risk Management (QRM) integrated with validated digital systems (eQMS & CSV), targeted vendor sourcing and tech-transfer, and logistics engineered for real-world supply chains. That combination accelerates safer product launches, from GMP biopharma operations in the USA and EU to medical device approvals in Ghana and agro-industrial scale-up across Africa.
Our Consulting Services
Phoenix Atlantic provides a diverse array of consulting services designed specifically for life-science and agro-industrial organizations. Our offerings encompass regulatory risk management, quality assurance leadership, validated digital systems, technology transfer, and logistics.
Quality & Regulatory Leadership
Provide QA/RA leadership that stabilizes operations, closes critical compliance gaps, and prepares drug and biologic manufacturers for inspections and approvals. We embed experienced QA/RA leaders into your team to run GMP governance, lead sterile and aseptic-control programs, and own validation and release activities until permanent leadership is in place.
Regulatory Strategy & Market Access
Design and execute regulatory pathways that align product strategy with target-market requirements. For biopharma clients we map FDA and EMA submission strategies (IND/CTA, CTD/CMC components); for device and agro clients we prepare dossiers and local registration strategies for Ghana and regional African markets.
Quality Risk Management (QRM)
Establish a defensible, repeatable QRM framework that prioritizes risk reduction across product, process and supplier dimensions. We align with ICH Q9 / ISO 14971 (and HACCP where applicable) to deliver FMEA-based prioritization, control plans, and eQMS-integrated monitoring that drive risk-based decisions.
Modernize quality operations with validated digital systems that reduce manual risk, improve traceability, and enable audit-ready records. We manage vendor selection, computerized system validation (CSV), and rollout of digital SOPs and training for GMP environments.
Manufacturing, Tech-Transfer & Scale-Up
Ensure repeatable production and successful scale-up by standardizing transfer artifacts, control strategies and validation approaches for both sterile and non-sterile lines. We manage readiness assessments, pilot batches and validation activities to minimize first-run failures.