Farma Consulting & Partners
Farma Consulting & Partners is dedicated to implementing and optimizing quality systems within the life sciences sector. They focus on building lasting relationships with clients to bring products to market safely and efficiently, while continuously challenging the status quo through their expertise in regulations and quality management. Their mission emphasizes delivering high-quality services in QA, QP, and validation activities, fostering partnerships, and supporting clients in navigating complex regulatory environments.
Industries
Nr. of Employees
small (1-50)
Farma Consulting & Partners
Products
Validation
Validation and qualification services ensuring facilities, equipment, utilities, computer systems, and processes comply with EudraLex Volume 4 and pharmaceutical manufacturing standards.
QA, QP and validation activities
Consulting and partnership services for quality assurance, qualified person (QP), and validation activities within the life sciences sector.
Qualified Person Services
Professional Qualified Person (QP) services providing batch release, regulatory compliance, and supply chain oversight for commercial and clinical pharmaceutical products in the European market.
CSV
Computerized System Validation (CSV) services to ensure the reliability and integrity of critical data, patient safety, and regulatory compliance such as FDA 21 CFR Part 11 and EU GMP Annex 11.
Quality Assurance Consulting Services
Pragmatic and personalized QA consulting services tailored to the life sciences and pharmaceutical sectors, focusing on risk identification, process enhancement, and regulatory compliance.
Validatie & kwalificatie
Expert consulting and guidance in validation and qualification for pharmaceutical manufacturing, including facilities, equipment, utilities, and computer systems.
Validation
Validation and qualification services ensuring facilities, equipment, utilities, computer systems, and processes comply with EudraLex Volume 4 and pharmaceutical manufacturing standards.
QA, QP and validation activities
Consulting and partnership services for quality assurance, qualified person (QP), and validation activities within the life sciences sector.
Qualified Person Services
Professional Qualified Person (QP) services providing batch release, regulatory compliance, and supply chain oversight for commercial and clinical pharmaceutical products in the European market.
CSV
Computerized System Validation (CSV) services to ensure the reliability and integrity of critical data, patient safety, and regulatory compliance such as FDA 21 CFR Part 11 and EU GMP Annex 11.
Quality Assurance Consulting Services
Pragmatic and personalized QA consulting services tailored to the life sciences and pharmaceutical sectors, focusing on risk identification, process enhancement, and regulatory compliance.
Validatie & kwalificatie
Expert consulting and guidance in validation and qualification for pharmaceutical manufacturing, including facilities, equipment, utilities, and computer systems.
Services
Consulting to design, implement and optimize QA processes and QMS documentation for life-sciences organisations.
Design and implementation of medical device QMS aligned with ISO 13485:2016, including process mapping and documentation.
Support for QP activities and batch release processes, including documentation review and release decision support.
Audit planning and execution for GMP/GDP compliance, including gap analysis, audit reports and corrective action planning.
Development and delivery of IQ/OQ/PQ protocols, qualification execution and reporting for equipment and production lines.
Risk-based CSV services including impact analysis, test protocol development and execution, documentation, and training aligned with Part 11 and Annex 11 expectations.
Consulting to design, implement and optimize QA processes and QMS documentation for life-sciences organisations.
Design and implementation of medical device QMS aligned with ISO 13485:2016, including process mapping and documentation.
Support for QP activities and batch release processes, including documentation review and release decision support.
Audit planning and execution for GMP/GDP compliance, including gap analysis, audit reports and corrective action planning.
Development and delivery of IQ/OQ/PQ protocols, qualification execution and reporting for equipment and production lines.
Risk-based CSV services including impact analysis, test protocol development and execution, documentation, and training aligned with Part 11 and Annex 11 expectations.
Expertise Areas
- Quality assurance
- Quality management system (QMS) design and implementation
- Computerized system validation (CSV) and data integrity
- Regulatory compliance (EU/FDA) and audit readiness
Key Technologies
- Computerized system validation (CSV)
- Electronic batch records / MES
- Serialization and aggregation systems
- Verification routing / product verification systems