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
engineering
quality management
regulatory compliance
operational excellence
new product introduction
technology transfer
manufacturing & supply
 

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.