Consulting, Audits, Compliance

sophida provides expertise in special fields in health care. We are going to share our knowledge with you by offering:


Consulting and support services related to clinical trials (medicinal products and medical devices

Our services include consulting and support regarding planning and preparation or review of study documents, support in regard to clinical trial application towards competent authorities, ethics committees and/or medical directions as well as continuous support and consultancy during study conduct. Furthermore, our portfolio includes audits as well as inspection readiness/ inspection support.Due to our experience and know-how within the field of clinical trials we are aware of all requirements and needs of involved parties, such as regulatory bodies, industry/sponsor as well as clinical trials sites including sites associated to university.


Consulting and support service Quality Management and process optimization in health care

We are able to support you regarding selection, strategic orientation and focused development of your management system. In addition, we are providing individual support services according to your needs, such as document preparation and/or revision, detailed analysis and optimization of procedures as well as process specifications, practical guidance and training of involved team members.


Preparation, conduction and follow up of audits

Based on our longstanding experience regarding audits and regulatory inspections we are able to provide you with support (preparation, conduction and follow up) related to internal system audits (quality management) as well as individual focused audits according relevant requirements. For example, we do offer focused process audits and risk audits within the clinical field, compliance audits, qualification and/or supplier audits (e.g. GDP), and mock inspections (AMG and AMBO, MPG, GDP etc).