Pharmaceutical Quality Systems (PQS) design, implementation, assessment, optimisation, and ongoing effectiveness monitoring.
Greenfield Manufacturing Projects, including facility qualification, validation, quality system development, and support for Manufacturer's and Importer's Authorisation (MIA) applications.
GMP, GDP and GLP Compliance assessments, auditing, remediation, and regulatory support.
Data Integrity and Data Governance Programmes aligned with EU GMP, MHRA, FDA, and global regulatory expectations.
Regulatory Inspection Readiness, including comprehensive mock MHRA, FDA, and EU GMP inspections.
Supplier, Vendor and Contract Manufacturing Organisation (CMO) Quality Management and oversight.
Quality Control Laboratory Excellence, analyst competency development, laboratory investigations, OOS reduction, and testing efficiency improvements.
Analytical Method Development, Validation and Verification in accordance with ICH and pharmacopoeial requirements.
Stability Programme Design, Review and Regulatory Compliance Support.
Supplier Qualification / Auditing, Internal Auditing, Self-Inspection Programmes and Compliance Remediation.
ISO 9001:2015 Quality Management Systems implementation, certification, and recertification support.
Deviation Management, Root Cause Analysis, Investigations and CAPA Excellence Programmes.
Quality Documentation Development, including SOPs, Site Master Files, policies, procedures, and quality governance frameworks.
Validation and Qualification Services, covering facilities, utilities, laboratories, manufacturing equipment, processes, cleaning validation, and computerised systems.
GMP Training, Leadership Development and Quality Culture Transformation Programmes.
Continuous Improvement and Operational Excellence Initiatives that enhance compliance, efficiency, quality performance, and business results.
