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.