Packaging & process components
Pharmaceutical and medical device manufacturers face increasing regulatory scrutiny on extractables and leachables (E&L), packaging qualification, and single-use systems compliance. Evolving global regulatory expectations require a risk-based and scientifically justified approach. Our consulting services support primary packaging risk assessment, process components qualification, E&L validation planning, and toxicological evaluation.
We help you define compliant testing strategies, manage change impact, and prepare audit-ready documentation to ensure regulatory approval and lifecycle compliance.
Risk assessment of primary packaging materials in contact with pharmaceuticals, including extractables and leachables evaluation and GMP compliance support.
Process components evaluation (USP <665>/<1665>)
Scientific and regulatory consulting for polymeric components, like single-use systems, and process components in alignment with USP <665> and <1665> requirements.
Primary packaging and process components (ICH Q3E)
Scientific and regulatory consulting for both primary packaging and process components in alignment with ICH Q3E requirements.
Primary packaging qualification strategy
Development of packaging qualification strategies including risk-based testing, regulatory documentation, and lifecycle compliance planning according to worldwide markets.
Risk-based testing strategy
Definition of risk-based analytical testing strategies for packaging and manufacturing components to ensure regulatory approval readiness.
Impact & change assessment
Regulatory impact assessment of material or supplier changes, including documentation updates and variation support.
Focus on E&L consulting
Risk assessment (primary packaging and process components)
Extractables and leachables risk assessment consulting for packaging and manufacturing systems used in pharmaceutical and medical device applications.
E&L validation plan
Preparation of E&L validation plans aligned with USP <1663>/<1664>/<1665>/<665>, ICH Q3E guideline, and regulatory submission requirements. Consulting support for E&L study design, document review, analytical strategy, and regulatory data interpretation.
Toxicological risk assessment
Toxicological evaluation of extractables and leachables including:
- Permitted Daily Exposure (PDE) derivation
- Cumulative Exposure Assessment Evaluation of patient exposure from multiple packaging and process materials in accordance with regulatory expectations
Extractables / Leachables study design and review
Consulting support for E&L study design, protocol review, analytical strategy, and regulatory data interpretation.
Change assessment and documentation review
Regulatory documentation review and gap analysis following packaging or component modifications.