Consulting in pharmaceutical compliance

The requirements for quality assurance systems in the life science industry (pharmaceuticals, cosmetics, medical devices and food) are constantly increasing. Current incidents are leading to corresponding tightening and adjustments by legislators and the relevant authorities. Efficiency and effectiveness are to be further improved with increasingly complex workflows and supply chains. Companies often lack the experience and human resources to implement all these requirements.

With experience from many successful compliance projects, Chemgineering supports you in maintaining an overview of the conflicting regulatory and corporate requirements and in producing efficiently and compliantly in the long term.

Risk assessment and risk management

Risk assessments and risk management are our tools for solution-oriented GMP compliance consulting. We focus on the aspects that are really relevant to quality and systematically check all areas. With the experience of our specialists, the end result of your compliance project is not a mountain of paper and frustrated employees, but GMP-compliant systems and processes that withstand audits at the first attempt.

Quality management systems: develop, introduce, improve

Chemgineering supports you in the introduction of a compliant quality management system tailored to your company according to your specific requirements, for example:

ISO (22000, 13485, 17025, 22716)
European Guidelines (2009/94/EC, Eudralex Volume 4, 1223/2009)
FDA (21 CFR Parts, 111, 210&211,225 & 226, 820)
AMG (Germany)
revHMG (Switzerland)
AMG (Austria)
Norms (ASTM)

As part of your team, we work with you to develop a system tailored to your company and your needs and accompany you through the entire life cycle. From development to implementation and monitoring in day-to-day work.

Inspections and audits: prepare, manage, pass

The authorities have announced their visit? An important customer wants to carry out an audit to check the agreed measures? Do you have many suppliers but too few resources to carry out the necessary audits? With experienced auditors and a professional organization, we support you in the preparation and organization of inspections and audits. With the help of mock audits, we put your systems and processes through their paces, draw up a report and help you implement improvement measures. Following the actual audit by the authorities, we support you in the evaluation of action plans and responses to the authorities.

Validation: conception, planning, implementation

The validation of procedures, methods and processes is standard practice. You think. Designing, planning and carrying out validation requires more than just knowledge of the relevant rules and regulations. What sounds simple is difficult to implement in practice if there is a lack of experience. With the know-how from many successfully completed validation projects, we support you in the validation of processes and analytical methods. The validation concepts we have developed have already been tested several times by authorities and assessed as compliant. We always focus on your needs and the requirements of the product or process. This gives you a sustainable concept that is easy to implement. We accompany you through the entire validation process, from development to implementation on site. The training of your employees goes without saying.