BIOPROCESS ENGINEERING CONSULTANCY

We provide specialized bioprocess engineering consultancy to support GMP-regulated manufacturing across the full product lifecycle — from concept and regulatory strategy through technology transfer, validation, and commercial operations.

Our consultancy services include:

• GMP and regulatory impact assessments, including change impact evaluation (quality, contamination risk, and compliance implications).

• Development of Contamination Control Strategy (CCS) and risk-based documentation (CCS & Risk Assessment reports).

• Risk assessments and process safety reviews (HAZOP, HACCP, QRM), including periodic HAZOP revalidation.

• Change control support, validation strategy development, and regulatory filing support.

• Engineering judgement on process step criticality (upstream vs. downstream, CIP vs. formulation) and risk mitigation strategies.

We support process definition and technical documentation through: Process Block Diagrams (PBD), Process Flow Diagrams (PFD), and Process Narratives, Holistic mass balance development and equipment sizing reviews, Utility philosophy evaluation and operational risk assessment, and Translation of process requirements into auditable, risk-based User Requirement Specifications (URS)

Our consultancy ensures that bioprocesses are scientifically robust, regulatory-compliant, operationally efficient, and scalable for commercial manufacturing.