Audits & Inspections

Having a former head of an European Inspectorate in our rows, we can assist you with all GxP and medical device audits and inspection issues. Audits of CROs, clinical sites, laboratories (GCLP, GCP, GLP, ISO), pre-inspection and post-inspection services will be performed worldwide. We have experience with most global players in this field, including PIC/S and WHO.

Regulatory Strategy

T.E.G. provides expert advice to define the appropriate regulatory strategy for your drug or medical device development program. We support your regulatory affairs efforts with in-depth knowledge of and experience with European and U.S. regulations to bring your product to market - effectively and efficiently.

Legal & Regulatory Compliance

Our experts provide a broad range of services around compliance, from pure consulting after assessment up to process development. We offer several service packages for data protection (DPO), assist in court cases and develop contracts. In addition, expert opinions (like financial company assessment for stock exchange), support by providing experts (e.g. PRRC) and in depth knowledge of Drug and Medical Device Law is amongst our core businesses.

Clinical Studies

With an extensive track record of excellence in clinical operations, our experts and partners offer your team the full range of consulting services. From clinical study planning, protocol development, recruitment and retention strategies, to medical writing and trial rescue management, T.E.G. will comprehensively support you to ensure the success of your clinical study.

Risk Management

Our team consists of highly-qualified and experienced strategic risk managers. We support clients on a wide array of risk assessment, data security, and safety compliance issues. We provide sustainable and feasible business solutions to manage threats from compliance, technology or operational errors. Integrated risk management systems are key items to tackle complex regulatory requirements, particularly for healthcare products, as well as to control potential uncertainties along the product life-cycle.

Quality Management

Creating sustainable growth by establishing high level quality management systems is one of our core business operations. We provide guidance with strategic development and improvement of business processes.

We implement technical and QM requirements such as ISO/IEC standards, lean management systems and establish systems e.g. according to ISO 14155, 15189, 13485 or for clinical trials. We aim to meet the exceed needs of our customers to get their products efficiently to market.