Ensuring regulatory compliance for drugs and medical devices

A-pharmaconsult, the specialist in regulatory affairs and quality consultancy for the life sciences industries, are experts in ensuring regulatory compliance for drugs and medical devices within multiple current regimes and throughout the product life cycle.

The compliance PDF brochure covers the evolution of regulations such as the European’s regulatory, GxP guidelines and the emergence of the EU’s Annex 11 MDR 2017/745 requirements.

Regulatory questions answered

The main steps and success factors involved in maintaining regulatory compliance of health products include:

• Management of change controls
• Preparation of gap analysis to identify priority action areas
• Mechanisms for updating the required technical documentation for medical devices and dossiers for drugs
• Preventative and risk mitigation strategies
• When support from an experienced regulatory team is required