- info@gmp-cgroup.com
- Naverland 2 2600 Glostrup
GMP Pharma Consult offers specialized consulting within GMP, quality assurance, validation and process optimization targeted at companies in the life science industry. With solid experience from both the pharma, biotech and medical device industries, solutions are delivered that are rooted in reality – always in accordance with applicable regulatory requirements and industry standards.
The approach is holistic and is based on the understanding of how regulatory requirements are best translated into efficient, documentable processes. This applies both in project start-up, in daily operations and in audit preparation. The emphasis is on structure, transparency and value-added consulting that makes a real difference in practice.
GMP Pharma Consult assists with both individual assignments and long-term collaborations – always with the goal of strengthening compliance, reducing risks and ensuring stable processes that can withstand external supervision and internal growth.
We help you ensure that all critical processes and systems are working as they should – every time. Our approach to validation is both structured and pragmatic, and we cover everything from developing validation plans to implementing DQ, IQ, OQ and PQ. We always work closely with your team and ensure documentation that meets both GMP, FDA and EMA requirements.
When new equipment or systems are to be introduced, it is crucial to have correct qualification and validation – both at the supplier and internally. We assist with FAT, SAT, supplier assessment, risk assessment and qualification of equipment, so that your investments meet the requirements and are ready for audit.
We support your production with everything from deviation management and CAPA to batch review and optimization of SOPs. We step in as a practical support in your daily operations and ensure that processes remain compliant, efficient and well-documented - without disrupting your flow.
Effective project management is essential to getting solutions to their destination. We offer structure, overview and progress in both small and large projects, and work with everything from change management to risk management and process optimization. We function as an integrated part of your team and ensure that both deadlines and quality requirements are met.
Quality should not just exist on paper – it should be felt in practice. We help develop and maintain your quality systems, including document management, CAPA, training programs and internal audits. Our goal is to strengthen your compliance and create a quality culture that can withstand both internal and external demands.
Risk assessment is at the heart of any strong quality system. We facilitate workshops, perform FMEAs and help document and manage risks in a way that creates both overview and robustness. Our approach is practical and customized – and always in line with current regulatory standards such as ICH Q9 and ISO.
Insight into everyday life in GMP-regulated environments ensures advice that is both compliant and operationally applicable.
Scalable solutions within DQ, IQ, OQ, PQ, FAT and SAT – tailored to your equipment, processes and regulatory requirements.
Professional management of risks through FMEA, gap analyses and documented decision-making in line with ICH Q9 and ISO standards.
All material is prepared with a focus on quality, traceability and compliance with applicable GMP requirements – ready for both internal review and external supervision.
GMP Pharma Consult offers specialized consulting within GMP, quality assurance, validation and process optimization targeted at companies in the life science industry. With solid experience from both the pharma, biotech and medical device industries, solutions are delivered that are rooted in reality – always in accordance with applicable regulatory requirements and industry standards.
The approach is holistic and is based on the understanding of how regulatory requirements are best translated into efficient, documentable processes. This applies both in project start-up, in daily operations and in audit preparation. The emphasis is on structure, transparency and value-added consulting that makes a real difference in practice.
GMP Pharma Consult assists with both individual assignments and long-term collaborations – always with the goal of strengthening compliance, reducing risks and ensuring stable processes that can withstand external supervision and internal growth.
