
pi services
pi specialises in business solutions tailored to the needs of our customers. We provide consultancy, project based, and business process outsourcing services in most quality-related challenges in the life sciences industry. The below list is regularly updated but please contact us if you are looking for something additional.
qualification & validation
-
Validation strategy, planning and management
-
Risk and Impact assessments
-
Process analytics and process optimisation
-
Pharmaceutical development (ICH Q7/Q8) and process performance qualification
-
Electronic records electronic signatures (ERES) assessment of production and laboratory systems
-
Qualification & validation of:
-
aseptic processing and sterilisation processes
-
solid and oral dosage processes
-
cleaning and decontamination processes
-
computer systems, electronic records and signatures
-
Excel spreadsheet validation (GAMP 5)
-
Analytical/microbiological method validation (ICH Q2)
-
controlled temperature units in production and laboratory environment with proprietary logging system
-
Laboratory equipment qualification and software validation (GAMP 5, USP 1058)
-
engineering
-
Feasibility studies, concept design, project scope planning and business case review
-
Project strategy, resourcing and implementation planning
-
Implementation of quality assurance systems in construction and procurement projects
-
Management of computerised and process automation systems
-
Coordination of operational and business interfaces with new projects
-
Briefing of specialist consultants and contractors for compliance requirements
-
Inspection and Test program management
quality management
-
Expertise in (inter)national regulations for drug products for human and veterinary use, blood and biological products, advanced therapy medicinal products (ATMP), medical devices (MD), companion diagnostics (CD), in-vitro diagnostics (IVD) and drug substance or active pharmaceutical ingredients (APIs), excipients and adjuvants
-
Quality risk management strategy and implementation (ICH Q9)
-
Quality system documentation effectiveness organisation and design (ICH Q10)
-
Quality assurance management and training
-
Quality training (GLP, GMP, GdocP, GDP) and competency
-
Implementation and training of ICH guidelines
-
Incident investigation including root cause analyses (RCA), corrective & preventive actions (CAPA) and operational quality management in production and laboratory environment
-
Supplier and contract manufacture assessment and management
-
Test method development, operational support, trend monitoring and quality review
-
Pre-and post-audit support
-
Internal audit programs for GMP, GDP and ISO13485
-
HACCP, Risk assessment and management
-
Development gap analysis and implementation of requisite programs
-
Data integrity (DI) review of production and laboratory processes
-
Product quality strategy and implementation
-
Auditing and compliance review
regulatory compliance
-
Verification of decontamination, cleaning and sterilisation
-
Process analytics, optimisation, verification and process validation
-
Supplier and contract manufacture assessment and management
-
Development of product and environmental test and monitoring programs
-
Continuous improvement and operational quality
-
Technical training, staff development ad competency
operational excellence (lean)
-
Quantitative analysis and statistical process control tool
-
Design of experiments (DoE), process understanding and verification strategies
-
Lean compliance and operational systems development
-
Leveraging compliance for quality
-
Operational quality and waste reduction initiatives
-
Continuous improvement based on your process
-
Process understanding, data capture and review
-
Business continuity planning
-
Technical training and staff development
new product introduction
-
Feasibility studies, due diligence and project scope planning
-
Product and design development strategy
-
Development and commercialisation project management and tracking
-
Tactical partnering and development of customer technical agreements
-
Technical review, capacity and scenario planning
-
Technical Transfer
-
Sourcing, engagement and management of third party specialists and suppliers
technology transfer
-
Process familiarization - Proof of Concept
-
Process Characterisation / Design of Experiments (DoE)
-
Site-to-Site Tech Transfer
-
Scale-Up Tech Transfer
-
Automation IT (Integration and IV&V)
-
Verification, Commissioning & Qualification
-
Process Validation
-
Reliability & Asset Performance Management
-
Operational Excellence
-
Outage Planning & Management
-
GMP Compliance: compliance audits, compliance action plans and response to inspection citations and warning letters
-
New Facilities Preparation: compliance expertise during the design phase, design review and assistance presenting the design to the FDA
-
Preparation for Regulatory Inspections: perform mock-inspections followed by preparation for inspections; implementation of action plans to address deficiencies and regulatory risk
-
Quality Assurance Services: Support QA department in all quality unit responsibilities
-
Regulatory Filing Preparation and/or Review: preparation, QA and GMP compliance review of regulatory filings
-
ICH Q10 Quality System Implementation
manufacturing & supply chain strategy
-
Business continuity and product supply security planning
-
Due diligence to establish new capacity or supply
-
Process re-engineering for profitability or product improvement
-
Development and commercialisation planning
-
Tactical partnering and development of customer technical agreements
-
Transfer of technology and products
-
Waste and environmental management.