ProductLife Group Announces Acquisition of Zwiers Regulatory Consultancy and Coverage Expansion to the Netherlands

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.

EMA Gives Extra Time to Marketing Authorization Holders to Manage Nitrosamine Risk

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.

eCTD: Harmony in Global Publishing Standards

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.

How to drive quality development of medicines with the “Quality by Design” approach

As a European-based company with experience in delivering advice and regulatory compliance services for development of pharmaceutical products, ProductLife Group can support you at all stages of the Quality by Design development process, offering strategic advice, resources, and expertise to support drug development as well as regulatory/CMC submissions.

Register to our news and events

Go to our Events to register
Go to our News to get insights

October 2022 Monthly Newsletter