Regulatory Compliance

The importance of reviewing regulatory compliance for inspections by both the authorities and the customer is steadily growing.  When considering the entire life cycle of a medicinal product or medical device there are often challenges related to quality assurance, production and regulations.  

Quality Pharma Projects develops practical solutions for your business by liaising legal regulations (EMA, ICH, MDR) and good manufacturing practices (GMP). We advise and assist you in integrating regulatory compliance as an integral part of the operational process.  

An effective change control system coordinates a controlled process flow, ensuring changes are monitored according to applicable regulatory standards.  It also optimizes the flow of critical information as all concerns and interests among the departments of a company involved in the change control process are brought together. 

QPP performs a comprehensive review of the quality system with a view to efficient implementation and practical relevance.  Upon completion we submit a strategic analysis detailing the path to system optimization.  By using synergy effects, improved communication and implementation of regulatory compliance in all areas, your company is able to effectively accommodate the growing demands of the market