Worldwide Regulations

Pharmaceutical and other healthcare firms face the complex challenge of complying with worldwide country-specific regulations. Since many firms wish to take advantage of the large US pharmaceutical market for products and devices, they must comply with US FDA regulations. However, most companies are also selling products to the growing worldwide pharmaceutical markets, and must also comply with regulations from other countries, for example specific regulations form the European Union (EU), United Kingdom (TGA), Canada (HPFBI), Japan, Australia, PIC/s and ICH.

Our staff of consultants including a large staff of senior validation consultants and engineers — provide in-depth knowledge and experience in key regulatory areas. These services are based on our expertise and understanding of laboratory, manufacturing and business processes. We can assist you with procedures and policies that need to be put in place to use or implement the system’s electronic records, audit trails and electronic security capabilities. We also offer procedural guidance and recommendations to our pharmaceutical clients for global regulatory compliance.

Invensys provides the right combination of experience and regulatory expertise and procedures for global regulatory compliance.