pi is experienced in providing services related to tech transfer and new product introduction across the globe. From initial user requirements and conceptual design studies, to process capability studies and modeling, to manufacturing trouble-shooting, we apply decades of experience, a hands-on approach and our tenacious attitude. We synchronize process science, manufacturing technology, engineering, management, business objectives, risk management and regulatory compliance.
We maintain an understanding of current directions in compliance, which include new approaches to manufacturing quality assurance: a quality systems approach (ICH Q10) that uses quality risk management principles (ICH Q9), grounded on a solid understanding of the process and product based on development studies (ICH Q8) and continuous improvement strategies, which use Process Analytical Technology – PAT (in accordance with FDA guidance on PAT).
We understand the principles, implementation details, and how these four documents interrelate to provide a comprehensive, science- and risk-based manufacturing quality system. We enhance our clients’ profitability by providing regulatory and compliance auditing, regulatory review and assessment, set-up and evaluation of quality systems to the pharmaceutical, biotechnology, process chemical, and related industries.
- Process Characterization / 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
- Owner’s Project 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