FISCHER-CARBALLOCONSULTINGTargeted support for complex challenges
Our services are organized around three complementary disciplines. Every engagement is scoped to your facilities, products, systems and business needs.
GMP & Quality Excellence
GMP Auditing & Inspection Readiness
Focused and full-site GMP assessments, inspection readiness reviews, audit reports and separately scoped CAPA follow-up.
FDA QMSR / ISO 13485 Assessments
Detailed requirement-level gap assessments, QMS document mapping, implementation evidence review, risk-ranked findings and remediation recommendations.
CAPA Effectiveness & ISO 14971 Risk Management
System and sample-based CAPA effectiveness reviews, and risk management system/file assessments against applicable requirements.
GMP Quality Systems Implementation & Remediation
Strategic QMS establishment, improvement, inspection-response advisory and remediation governance.
Selected regulatory and management-system frameworks
FDA GMP and QMSR requirements, ISO 13485, ISO 14971, EudraLex Volume 4 (EU Guidelines for Good Manufacturing Practice), ISO 22301 and ISO 31000. Applicability is established for each engagement.
Facility & Operational Readiness
GMP Facility Design & C&Q Advisory
GMP design review, material and personnel flows, contamination control, C&Q strategy, qualification planning, project Quality oversight and operational readiness. Strategic advisory, not licensed architectural or engineering design.
Interim Quality Leadership
Interim Quality Head/Director-level strategic leadership, operational Quality oversight and remediation governance, subject to agreed scope, authority and availability.
Enterprise Risk & Resilience
ISO 22301 Business Continuity Assessment
BCMS governance, business impact analysis, continuity plans, recovery arrangements, implementation evidence and management reporting.
Enterprise Risk & Operational Excellence Advisory
Risk governance, operational risk, resilience and continuous improvement support.
GMP Operational Resilience
Integrated assessment of GMP-critical processes, dependencies, continuity arrangements and recovery readiness, connecting Quality and Enterprise Risk expertise.
Engagements are tailored. Descriptions do not imply third-party certification or guarantees of regulatory outcomes.