Etienne Crombach

Provides consultative services from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance areas to pharmaceutical, class I/II/III medical device and biotech companies. Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and (pre) clinical consulting, implementation and remediation of quality management systems and documentation, inspection readiness and supply chain control.

Crombach Consultancy has the technical and regulatory expertise to support SME companies in managing and maintaining compliance with the applicable regulations regarding development, manufacturing and marketing activities, including the development and control of product technical files, submissions and reporting of data in accordance with applicable regulations to competent authorities and notified bodies.

Furthermore, Etienne Crombach is qualified and assigned by notified bodies SNCH and DEKRA to perform pan-European audits to the criteria relevant for medical devices (EN ISO 13485, MDD 93/42/EEC) on a subcontractor basis.