Our Consultancy Services offer high-level expertise and unique intellectual property to guide you through the Good Manufacturing Practices (GMP) landscape and applicable regulations.
We help our customers to solve their quality assurance and business challenges, realize profit margin optimization and regulatory compliance. We advise and serve !
Interim Management is part of our services, implementing high-level quality projects while we collaborate with your employees. We apply our experienced knowledge and hands-on to.
- Ensure Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) during product manufacturing, packaging, labeling, release, and distribution of your products.
- Provide GAP analyses of GMP/GDP systems and install corrective measures as appropriate.
- Identify the required Quality Systems Procedures (SOPs) and other pertinent documentation such as qualification and validation documentation, batch records, protocols, reports, test methods and product certification.
- Assure that quality management inputs are defined for the pre-approval dossier and further preparation of the Quality Management Report and continues improvement.
- Prepare for Approval Inspection by the Regulatory Agency or certification bodies, as applicable to the type of Industry.
- Implement and maintain Quality Management Systems (QMS) and deal with the transition challenges of quality management and quality assurance systems, from the design until the commercial process. Consequently, update the systems implemented as appropriate for the project status and following changes thereto.
We actively put in place solutions to reach your goals, some examples of successful projects:
- Execution of vendor assessments during the pre-approval phase of medicinal products (project based) at mid-size biotech companies. Supporting due-diligence processes.
- GAP assessment of GMP and Quality Management Systems based on Cosmetics Regulation, defining corrective and preventive measures, at mid-size cosmetics manufacturers.
- Interim management third party audits at Datwyler Sealing Solutions, Health Care.
- Consulting on the regulatory approval inspection readiness for QC laboratories, at Sanofi, Genzyme Flanders Biotech. Project Management.
- Audit management of subcontractors and suppliers at The Estée Lauder Companies. Preparing global audit checklists according to current GMP practices for OTC and non-OTC products.
- Implementation of a Quality Management System (QMS) at Johnson & Johnson, Janssen Pharmaceutica NV, development and commercial production of medicines and preservatives.