Our promise: Impact and Speed!

The range of services and knowledge in the field of “Regulatory Affairs” is broad and touches on a multitude of different directives, laws, regulations and standards. At the same time, internationalization leads to a variety of country-specific regulations with explicit differences in approval.

The core areas in this area are adaptations to the products as well as their labeling and testing prior to market launch. The creation and maintenance of technical documentation must comply with the requirements of the Medical Device Regulation (MDR) or the German Medicines Act (AMG) as well as the respective differences in international approvals. In addition to the FDA, the CFDA and PMDA must increasingly be taken into account here.

Our experts are experieced in:

• Risk analysis of the approval process taking into account all regulatory and normative requirements
• Creation and design of all information and forms relevant to the approval process
• Technical documentation
• Know-How in all regulatory requirements (AMG, MPG, MDR, MDD, AIMDD, MEDDEV, AMWHV, ISO 13485, ISO 14971, ISO 14155, ISO 20416, IEC 62366, IEC 62304)
• Support of certification processes

Clinical Affairs deals with questions relating to the clinical application of a medical device or pharmaceutical product. The aim of the activities is to prove that the products actually provide the clinical benefit in practical use that is set against the risk in risk management. The clinical benefit of the product must be supported by data and monitored and confirmed throughout the product life cycle.

The MDR and the AMG tighten the requirements for clinical evaluations. We offer the customer immediate expert support.

• Development of a Clinical Study Protocol (CSP)
• Creation of standard operating procedures (SOP) for uniform project implementation and preparation of study documents (protocol, eCRFs, patient information, investigator folders).
• Study design and recruitment of study participants
• Global study execution and monitoring (documentation, execution, follow-up, local regulation)

Medical devices and pharmaceuticals are subject to strict quality assurance requirements. This applies both to certification and approval procedures and to quality management of production and processes. In principle, both pharmaceuticals and medical devices must meet specific performance and safety requirements. Quality management monitors the entire production cycle - starting with the supply of materials through to product delivery. Central to this is that the product should meet customer requirements, production targets and regulatory and normative requirements. The tasks link closely with regulatory, manufacturing and R&D activities.

The refinement of quality management - and the focus on new topics and innovations is typically a process in which expertise is brought in from outside. With our staffingsolutions, we help to solve resource bottlenecks to the point.

• Planning, implementation, maintenance and further development of the quality management system according to EN ISO 13485, IVDD/ IVDR, FDA 21 CFR 820.100
• Supervision of conformity assessment procedures and approval procedures in European countries
• Execution and implementation of the CAPA process (Corrective and Preventive Action) along the standards ISO 13485, 21 CFR 820
• Creation, maintenance, management and updating of Q documents (VAs, AAs, SOPs, technical documentation)

• CIP / development processes (Six Sigma, Lean) and Development of technical design documents (ISO 13485, 21 CFR 820)
• Technical analysis of products, product applications and manufacturing processes
• Process and test method validation
• Construction planning / product development / design & documentation of manufacturing and testing concepts
• Patent monitoring

The MedTech sector as well as the pharmaceutical industry, which are dominated by medium-sized companies, have only limited resources for developing and implementing new manufacturing processes. Therefore it is important to involve production experts at an early stage.  And also to increasingly rely on innovation partnerships and distributed production strategies with specialized partners.

• Analysis and definition of the production process (PFMEA/FMEA, creation of manufacturing documents and process tools)
• Design planning
• Support in the preparation of documents relevant for admission
• Auditing and optimization of the procurement process for subcomponents
• Planning of the assembly process / production optimization (Industrial Engineering)
• Lean Management, CIP, Six Sigma

In order to further advance digitalization, interconnectivity and automation, the use of Artificial Intelligence, robotics as well as Machine Learning is of extraordinary importance. However, due to the creation and utilization of a large amount of data, cyber security is also playing an increasingly important role. Particularly in sectors such as medical technology and the pharmaceutical industry, where work is carried out with highly sensitive data, the protection of patient safety is a top priority, which is why the demand for IT experts in the field of cyber & network security is increasing dramatically on an international level.

• Implementation of IT compliance audits according to ISO 27001
• Creation and consulting in the life cycle of systems and solutions of relevant MES, LIMS, RIM, PV, CTMS as well as QM system providers
• Cyber & Network Security
• Integration of AI & Machine Learning Solutions
• Cloud / DevOps / IT Test Automation
• Data Engineering & Analytics