empatec regulatory services

Empatec Regulatory Services provides practical regulatory help and advice to companies who are developing, manufacturing, marketing or licensing products in the pharmaceutical or healthcare sectors. We deliver high quality services and cost-effective expertise. We work with client companies of all sizes from large multinationals to small and virtual organisations to help them meet regulatory objectives. For early stage technology companies we can establish the regulatory environment for new technologies. For small and virtual companies we can act as your outsourced regulatory function. For larger companies we can work to support your own regulatory department and project teams. For companies based outside the EU we can carry out gap analysis of your dossiers to assess EU suitability. For Active Pharmaceutical Ingredient manufacturers we can help with Master Files and EDQM Certificates of Suitability. For anyone needing regulatory or product information we can help with desk-based research. We know where to look for key information and can provide a cost-effective service even for very small projects / one-off queries.