Innovative solutions for the pharmaceutical, biotech, medical technology sectors, consumer care and nutrition
As an EPCMV partner/general planner, we work with our customers to develop solutions and plans for the pharmaceutical and biotechnology industries. Our clients include companies from the chemical and fine chemical industries as well as the cosmetics and food sectors.
Our interdisciplinary teams of highly qualified experts, including engineers, production and process specialists, offer the full breadth of expertise on process, guidelines and regulatory directives needed in this wide-ranging field. They combine their industry-specific expertise with state-of-the-art technologies to develop highly effective solutions that meet your individual challenges.
Efficient GMP planning and implementation for your production
Our expertise in the pharmaceutical sector begins with a well-founded analysis. Our subject matter experts (SMEs) use this to derive solution-oriented advice in the fields of active ingredient production, parenterals, clean media, containment and others. We support you in your technology selection, optimizing your existing systems and clean rooms, process sequences and zoning strategies to ensure compliance, and also offer comprehensive GMP auditing, operational excellence and qualification consulting.
Planning is a crucial step in all pharmaceutical industry projects. We specialize in providing comprehensive engineering and planning services for all phases from concept design (CD) to basic engineering (BD) and detail design (DD). We ensure that your production systems are optimally designed and integrated into the overall system and base our layouts, clean rooms and complex production facilities on process- and risk-based approaches (ICH Q9, ISPE guidance documents).
Implementing your pharmaceutical plants calls for meticulous coordination and project management. We coordinate all trades and suppliers to ensure that your project flows smoothly. Our comprehensive technical documentation safeguards compliance with all GMP and qualification aspects of your production facility.
Qualification is the key step for successfully commissioning and operating a system. Taking current regulations and guidelines into account right from the early planning phases, we prepare tender documents, risk analyses, validation master plans and risk-based test plans for DQ/IQ/OQ, giving you confidence that your systems meet the highest quality standards – for safe and efficient operation in a GMP environment.
