Managing through global challenges while ensuring product quality and integrity
Whether you’re a pharma or biotech from an established region looking to expand into an emerging market, or you’re looking to expand from a smaller, emerging region into a more established, mature market, expansion introduces new challenges with regulatory compliance and data integrity.
Regulations and specific requirements can greatly vary in each divergent market. While there may be basic alignment across countries and regions, there are still significant variances in regulations and level of detail of documentation required. Countries may use the same common technical documents, but the constructs you’re submitting vary and there are nuances to certain sections which must be addressed.
The quality of data required to prove product safety and efficacy and integrity of manufacturing data is a common objective of global regulatory bodies. So how can you take a proactive approach to improve your chances of success and level the regulatory playing field?
Complete the form opposite to take a closer look at five practical strategies to manage regulatory challenges while ensuring data quality and product integrity.