PhaToCon

Additional Info
(Quality Management)

Key aspects of our QM-services in Life Science:

Product Safety and Risk Assessment for Pharmaceuticals, Biopharmaceutical and Medical Devices are aspects that are already in R&D of lasting importance. Considering prospective regulatory relevant issues, increases the efficiency, precision and sustainability of the development process. By using quality management system based on industrial standards, you gain:

• Mutual acceptance (Investor - Partners - Supplier - Customer - Authority)
• Predictability of legal decisions (e.g. product liability, patent, health and safety, ... )
• Increased efficiency (by reducing preventable errors)
• Reliable data (by validated and qualified systems)
• QM acceptance (employees understand the processes including relevance and requirements)
• Transparency and traceability of data (with regard to prospective audits).

Consistently based on requirements
We especially support companies' founders, start-ups and SMEs in the life sciences in development and establishment of needs-based quality management systems for biological safety. Based on globally standardized industrial and regulatory quality management systems (GxP, ISO, ... ) and guidelines (OECD, ICH, ... ) we focus, above all, on practicability and the company-specific requirements. Our support leads to tailor-made quality management system de novo or based on already established quality strategies. As a result of our cooperation you obtain:

• a guided approach to the establishment of a needs-based quality management system or a transparent image of the strengths and weaknesses of your existing quality management system,
• a diagnosis of each individual quality strategy,
• a plan which potentials to increase efficiency and minimize risk should be exhausted directly,
• a transparent image of the highest error risks of the equipment, processes and methods,
• guidance on improvement of QM processes in terms of risk identification, quality assessment, error handling and control.

High efficiency
We provide proven consulting and management services in all aspects for approval of the biological safety of your product and respective quality management. We support you individually and complement both, your resources and your skills, quickly and flexibly. Depending on your requirements we relieve at certain critical points - or we accompany a project continuously over a long period of time. With our "hands-on" mentality, we perform practical quality management from a scientific perspective.


QM projects in research and development

Individual preclinical project management
The focus of our services are pre-clinical studies, methods and research to be carried out under defined needs-based quality assurance systems. Since preclinical studies are the key for further development (e.g. clinical trials) and the scientific basis for your future strategic decisions, the studies should be reviewed under scientific, regulatory and quality aspects.

Validation, Qualification and Process Optimization
Standardization is an essential element of QM to increase efficiency. Processes initially need to be optimized and validated subsequently. Equipment needs to be qualified to generate continuously reliable data. Both, validation and qualification, are of essential importance in the international regulations. We support you to meet the requirements defined in the Directives.

Technology and Method Transfer
Technology and method transfer of biological systems within a company or between cooperating companies must be carried out under clearly defined conditions. We support you in the definition of specifications and review the process using appropriate validity studies (Change Control).

Toxicological assessment and validity
Each pivotal study - whether performed in-house or by contract research institute - should be reviewed under scientific and regulatory point of view and thereby show their validity. Particularly when results do not meet expectations or working hypothese, the validity of the data must be checked. As an independent external partner, experienced in responsibility for solid reliable results, we ensure that your results meet all validity criteria. If necessary, we provide toxicological expertise to facilitate your position.