October 2022 Monthly Newsletter

In the wake of recent acquisitions such as Quoretex in May 2022 and Pharma IT in June 2022, ProductLife Group (PLG), the global provider of regulatory and compliance services for the life sciences industry, enhances its comprehensive suite of development services by acquiring Zwiers Regulatory Consultancy.

Over the last four years Marketing Authorization Holders (MAHs) have been responding to critical directives from global regulators in addressing the safety risk of nitrosamine impurities in chemical and biological human medicines. In previous blogs, ProductLife Group (PLG) has summarised the three-step process proposed by the European Medicines Authority (EMA) for MAHs to review their manufacturing processes for products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities.

PLG has experience in supporting MAHs fulfill their responsibilities in submitting timely and accurate information with regard to updating Marketing Authorization Variations at step 3.

With the transition across Europe to the IDMP altering the way that information is globally exchanged, it is becoming increasingly important to have a RIMS in place to harmonize submissions and to help you better manage your data. ProductLife Group (PLG) can provide you with the knowledge and expertise to help you navigate these changes.

At PLG, we are experts in developing and submitting regulatory applications globally. With many countries implementing the eCTD as the mandatory format for submissions, our experts can help you reach eCTD readiness, whilst offering knowledge and insights to help you navigate all major markets.