Unsere Stärke ist ein umfassendes Leistungsspektrum, mit dem wir Ihnen das komplette Zulassungsverfahren vom GLP-Report bis zum fertigen Dossier und der entsprechenden Betreuung vor, während und nach der Zulassung aus einer Hand anbieten.
Unsere Services im Bereich Crop Protection
Registrierungs- und Projektmanagement, weltweite Zulassung
Komplette Erstellung von Zulassungsdossiers
Analyse und vorläufige Bewertung der verfügbaren Daten inkl. Check of Completeness
Strategische Beratung, Registrierungsempfehlungen
Management und Monitoring der relevanten Studien
Identität und physikalisch-chemische Parameter
Toxikologie und Human Exposure
Nahrungsmittelsicherheit, Dietary Risk Assessment und Rückstände
The legal framework for medical devices has been established in the EU by the Medical Devices Directive (93/42 / EEC, MDD) and currently the Medical Devices Regulation (2017/435, MDR). This classifies medical devices into four classes (I, IIa, IIb, III), taking into account the hazard potential. In the classification, we advise you and help with the preparation of technical and regulatory documentation. The classification of your "borderline products" is also in good hands with our specialists.
Internationally in good hands
With our subsidiaries and partners, we are able to open the global market for global registration of your products with on-site employees. Currently, around 80 experts worldwide work in the field of medical devices for the knoell Group.
Auditing / ISO 13485
We support the implementation of a suitable quality management system and its maintenance through a coordinated audit program. The audit program refers both to internal audits of the quality management system and to supplier audits. Our experts are trained senior auditors and have extensive hands-on experience. Customer needs are always paramount in order to be able to deliver tailor-made, high-quality solutions.
Evaluation and preparation of technical documentation
The certification does not only consist of a suitable quality management system but also requires corresponding technical documentation. We support you in the needs analysis and create a technical documentation that meets the requirements of each certification. These include the creation of a suitable document structure, risk management documentation, clinical and biological assessment, validation activities and product labeling. The scope is defined together with the customer in order to always achieve optimal solutions.
Strategic and regulatory consulting services
The legal and regulatory framework worldwide is complex and sometimes very different. We support you with our extensive knowledge in product registration and accompany you on your way to product approval. You determine to what extent we should work for you. Furthermore, we support you in the optimization of existing processes in order to fulfill the future requirements efficiently and economically.