Medicine
We offer comprehensive services related to implementation, expansion, optimization and support of the certification of quality management systems (QMS) for the pharmaceutical industry. Our range of services covers all areas - from the initial gap analysis via the creation of tailor-made QM processes in accordance with EU GMP and GDP requirements, to preparation for official inspections and certifications. We are also happy to take on the qualification of suppliers.
We specifically identify weak points and potential for optimization in your business’
existing quality assurance system. Our experts carry out comprehensive GAP analyses and evaluate your processes with regard to regulatory requirements (EU-GMP/GDP, AMG, AMWHV and relevant international guidelines). We develop a concrete catalog of measures to close gaps and facilitate preparation for the certification process.
We support the development and implementation of a complete
pharmaceutical QMS that is specifically tailored to the needs of your company. These include standard operating procedures (SOPs), process documentation, training and review concepts as well as risk management strategies that meet regulatory requirements.
Our experienced experts will help you prepare certification audits and inspections by authorities or certification bodies. We help you analyze audit reports, develop corrective actions and implement and maintain a high level of compliance in the long term.
A crucial component of a functioning quality management system in the pharmaceutical industry is monitoring its own suppliers and the conclusion of detailed quality agreements. We support you in the selection, qualification and regular assessment of your suppliers in accordance with EU GMP standards. We also offer support in the creation and testing of
quality agreements to keep your partnerships legally secure and in place to ensure compliance with the requirements.
We specifically identify weak points and potential for optimization in your business’
existing quality assurance system. Our experts carry out comprehensive GAP analyses and evaluate your processes with regard to regulatory requirements (EU-GMP/GDP, AMG, AMWHV and relevant international guidelines). We develop a concrete catalog of measures to close gaps and facilitate preparation for the certification process.
We support the development and implementation of a complete
pharmaceutical QMS that is specifically tailored to the needs of your company. These include standard operating procedures (SOPs), process documentation, training and review concepts as well as risk management strategies that meet regulatory requirements.
Our experienced experts will help you prepare certification audits and inspections by authorities or certification bodies. We help you analyze audit reports, develop corrective actions and implement and maintain a high level of compliance in the long term.
A crucial component of a functioning quality management system in the pharmaceutical industry is monitoring its own suppliers and the conclusion of detailed quality agreements. We support you in the selection, qualification and regular assessment of your suppliers in accordance with EU GMP standards. We also offer support in the creation and testing of
quality agreements to keep your partnerships legally secure and in place to ensure compliance with the requirements.
Your benefit
Ensuring EU GMP and GDP compliance
Minimizing risks in supplier management
Efficient preparation for inspections and certifications
Optimization of quality processes and contract management
Sustainable assurance of product quality and patient safety
Medical Devices (Class I - III)
We offer comprehensive support in development, optimization and certification of quality management systems (QMS) in the area of medical devices in accordance with the current regulatory requirements of the EU-MDR, ISO 13485 and FDA specifications. Our range of services also includes the management of suppliers and contracts as well as the support through the entire approval process (regulatory affairs) for medical devices of all classes (I, IIa, IIb, III).
We analyze existing QM systems with the processes introduced in your company to fill gaps in regulatory requirements (e.g. EU-MDR,
ISO 13485, FDA 21 CFR Part 820). We evaluate the processes, technical documentation and risk management.
We then develop a concrete catalog of measures for optimization of the processes to close gaps and prepare to facilitate the certification process and audits.
We then develop a concrete catalog of measures for optimization of the processes to close gaps and prepare to facilitate the certification process and audits.
Our specialists develop and implement a QM system that is specifically tailored to the requirements of your medical devices. This includes the creation of SOPs, the review of technical documentation and risk management files. The goal is to position your company in such a way that the regulatory requirements are met and quality management with the continuous improvement approach is able to achieve this in the long term.
We accompany you through the entire certification process and prepare you for an audit by your designated body and, if applicable, an official inspection
before. We are also happy to undertake mock audits for ISO 13485 certification and in preparation for FDA inspections. Our experts ensure that your technical documentation is complete and all regulatory requirements are met.
Stable supplier management is essential for ensuring quality and delivery ability of medical products. We support you with the qualification, evaluation and regular monitoring of suppliers. In addition, we create quality agreements and check existing contracts for compliance with the regulatory requirements.
We accompany you in the approval process for medical devices of all classes. We offer comprehensive services: from the preparation of technical documentation regarding registration with notified bodies to support with the submission to authorities abroad. We take into account the requirements of the EU MDR, FDA and other international markets. Our focus is on the efficient preparation of CE certifications, FDA 510(k) or PMA submissions and more international approvals (e.g. Canada or Australia).
We analyze existing QM systems with the processes introduced in your company to fill gaps in regulatory requirements (e.g. EU-MDR,
ISO 13485, FDA 21 CFR Part 820). We evaluate the processes, technical documentation and risk management.
We then develop a concrete catalog of measures for optimization of the processes to close gaps and prepare to facilitate the certification process and audits.
We then develop a concrete catalog of measures for optimization of the processes to close gaps and prepare to facilitate the certification process and audits.
Our specialists develop and implement a QM system that is specifically tailored to the requirements of your medical devices. This includes the creation of SOPs, the review of technical documentation and risk management files. The goal is to position your company in such a way that the regulatory requirements are met and quality management with the continuous improvement approach is able to achieve this in the long term.
We accompany you through the entire certification process and prepare you for an audit by your designated body and, if applicable, an official inspection
before. We are also happy to undertake mock audits for ISO 13485 certification and in preparation for FDA inspections. Our experts ensure that your technical documentation is complete and all regulatory requirements are met.
Stable supplier management is essential for ensuring quality and delivery ability of medical products. We support you with the qualification, evaluation and regular monitoring of suppliers. In addition, we create quality agreements and check existing contracts for compliance with the regulatory requirements.
We accompany you in the approval process for medical devices of all classes. We offer comprehensive services: from the preparation of technical documentation regarding registration with notified bodies to support with the submission to authorities abroad. We take into account the requirements of the EU MDR, FDA and other international markets. Our focus is on the efficient preparation of CE certifications, FDA 510(k) or PMA submissions and more international approvals (e.g. Canada or Australia).
Your benefit
Ensuring compliance with legal and regulatory requirements
Efficient preparation for audits and the certification process
Risk minimization through optimized supplier and contract management
Shortened approval times for new medical devices
Sustainable assurance of product quality and patient safety
Nutrition supplements and cosmetics
We offer comprehensive regulatory advice for companies involved in the manufacture, marketing and distribution of food supplements (NEM) and cosmetics. Our goal is to guide you safely through the complex legal requirements in the EU and other international markets and to bring your products to market quickly and in compliance with the law.
We support you in the development of new products by ensuring that ingredients, labeling and product claims comply with the applicable regulations. For food supplements, we particularly take into account the requirements of food laws (e.g. EU Regulation 1169/2011, Health Claims Regulation) and for cosmetics, the EU Cosmetics Regulation (EC No. 1223/2009).
We support the entire process of product approval and registration, both for food supplements and cosmetics. This includes the preparation of the necessary safety reports, product information files (PIF) and registration with the relevant authorities, such as via the CPNP (Cosmetic Products Notification Portal) for cosmetics.
Correct labeling is essential to avoid warnings and official complaints. We check your labels, packaging and advertising statements for compliance with legal requirements. Especially in the area of health claims for food supplements, we ensure that only permissible health-related information is used.
We check your ingredients for compliance with the legal positive lists and maximum quantity regulations. For cosmetics, we also carry out an assessment of the safety requirements, including testing for possible allergenic or prohibited substances.
We support you with ongoing market monitoring and help you to keep your products legally compliant in the long term. This includes adapting to new regulatory developments and legal changes. We also support you in preparing risk analyses, product notifications and recall procedures.
We accompany you during official inspections and audits, ensure complete documentation and help you to correct any deficiencies.
We support you in the development of new products by ensuring that ingredients, labeling and product claims comply with the applicable regulations. For food supplements, we particularly take into account the requirements of food laws (e.g. EU Regulation 1169/2011, Health Claims Regulation) and for cosmetics, the EU Cosmetics Regulation (EC No. 1223/2009).
We support the entire process of product approval and registration, both for food supplements and cosmetics. This includes the preparation of the necessary safety reports, product information files (PIF) and registration with the relevant authorities, such as via the CPNP (Cosmetic Products Notification Portal) for cosmetics.
Correct labeling is essential to avoid warnings and official complaints. We check your labels, packaging and advertising statements for compliance with legal requirements. Especially in the area of health claims for food supplements, we ensure that only permissible health-related information is used.
We check your ingredients for compliance with the legal positive lists and maximum quantity regulations. For cosmetics, we also carry out an assessment of the safety requirements, including testing for possible allergenic or prohibited substances.
We support you with ongoing market monitoring and help you to keep your products legally compliant in the long term. This includes adapting to new regulatory developments and legal changes. We also support you in preparing risk analyses, product notifications and recall procedures.
We accompany you during official inspections and audits, ensure complete documentation and help you to correct any deficiencies.
